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Impact on Carriage, Acute Otitis Media, Immuno & Safety of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00839254
Recruitment Status : Completed
First Posted : February 9, 2009
Results First Posted : July 27, 2020
Last Update Posted : August 31, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:

The aim of this study is to assess the effectiveness of GSK Biologicals' pneumococcal conjugate vaccine (GSK1024850A) in preventing invasive disease caused by S. pneumoniae or H. influenzae and in reducing occurrence of hospital-diagnosed pneumonia cases, tympanostomy tube placement and outpatient antimicrobial prescriptions in children starting vaccination below 18 months of age. These data will be collected from the national registers and will be analyzed in combination with data collected for subjects enrolled in a large scale cluster-randomized study 111442.

The study will also assess the immune response to the GSK1024850A vaccine and the impact of the vaccine on occurrence of acute otitis media, carriage, safety in children starting vaccination below 18 months of age.


Condition or disease Intervention/treatment Phase
Infections, Streptococcal Streptococcus Pneumoniae Biological: Pneumococcal conjugate vaccine Synflorix (GSK1024850A) Biological: GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine) Biological: GSK Biologicals' Havrix TM vaccine (Hepatitis A vaccine) Phase 3

Detailed Description:
The protocol posting has been updated with regards to the outcome measures following Protocol amendment 4, 12 August 2011.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6181 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Impact on Nasopharyngeal Carriage, Acute Otitis Media, Immunogenicity and Safety of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A
Actual Study Start Date : February 18, 2009
Actual Primary Completion Date : January 31, 2012
Actual Study Completion Date : January 31, 2012


Arm Intervention/treatment
Experimental: 10Pn3+1-6W-6M/053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
Biological: Pneumococcal conjugate vaccine Synflorix (GSK1024850A)
2, 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination

Experimental: 10Pn2+1-6W-6M/053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks, followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
Biological: Pneumococcal conjugate vaccine Synflorix (GSK1024850A)
2, 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination

Active Comparator: Ctrl3+1-6W-6M/053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to a 3-dose primary vaccination schedule with an interval of at least 4 weeks between doses followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (3+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
Biological: GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine)
3 or 4 Intramuscular injections, depending on the age at the time of first vaccination only for children < 12 months of age at the time of first study vaccination.

Active Comparator: Ctrl2+1-6W-6M/053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 6 weeks to 6 months at enrolment. Subjects received the Engerix B vaccine (called also HBV vaccine) according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (2+1 Infant Schedule). The vaccine was administered intramuscularly in the thigh.
Biological: GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine)
3 or 4 Intramuscular injections, depending on the age at the time of first vaccination only for children < 12 months of age at the time of first study vaccination.

Experimental: 10Pn7-11M/053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Biological: Pneumococcal conjugate vaccine Synflorix (GSK1024850A)
2, 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination

Active Comparator: Ctrl7-11M/053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 7 to 11 months at enrolment. Subjects received the Engerix B (called also HBV) vaccine according to a 2-dose primary vaccination with an interval of at least 8 weeks followed by a booster dose of the same vaccine with an interval of preferably 6 months since the previous vaccine dose (minimum 4 months) (7-11M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Biological: GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine)
3 or 4 Intramuscular injections, depending on the age at the time of first vaccination only for children < 12 months of age at the time of first study vaccination.

Active Comparator: 10Pn12-18M/053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Synflorix (called also 10Pn-PD-DiT, 10Pn or GSK1024850A) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Biological: Pneumococcal conjugate vaccine Synflorix (GSK1024850A)
2, 3 or 4 Intramuscular injections, depending on the age at the time of first vaccination

Experimental: Ctrl12-18M/053 Group
Subjects in this group were subjects enrolled in the 10PN-PD-DIT-053 (NCT00839254 - EUDRACT 2008-006551-51) study, aged 12 to 18 months at enrolment. Subjects received the Havrix (called also HAV) vaccine according to a 2-dose vaccination with an interval of at least and preferably 6 months between doses (12-18M Schedule). The vaccine was administered intramuscularly in the thigh or in the deltoid region of upper arm, provided the muscle size was adequate.
Biological: GSK Biologicals' Havrix TM vaccine (Hepatitis A vaccine)
2 Intramuscular injections only for children >= 12 months of age at the time of first study vaccination.




Primary Outcome Measures :
  1. Person Year Rate as Regards Subjects With Culture-confirmed IPD Due to Any of the 10 Pneumococcal Vaccine Serotypes. In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course. [ Time Frame: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months). ]
    The PYAR (Person-Year Rate) as regards subjects with culture-confirmed invasive pneumococcal disease (IPD) due to any of the pneumococcal vaccine serotypes was tabulated (vaccine pneumococcal serotypes = serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F). PYAR was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.

  2. Person Year Rate as Regards Subjects With Culture-confirmed IPD Due to Any of the 10 Pneumococcal Vaccine Serotypes. In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course. [ Time Frame: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months). ]
    The PYAR (Person-Year Rate) as regards subjects with culture-confirmed invasive pneumococcal disease (IPD) due to any of the pneumococcal vaccine serotypes was tabulated (vaccine pneumococcal serotypes = serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F). PYAR was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.


Secondary Outcome Measures :
  1. Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course. [ Time Frame: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months). ]
    The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.

  2. Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course. [ Time Frame: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months). ]
    The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.

  3. Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 7-11 Months Schedule. [ Time Frame: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months). ]
    The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.

  4. Person Year Rate in the Prevention of Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 12-18 Months Schedule. [ Time Frame: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months). ]
    The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.

  5. Person Year Rate in the Prevention of Probable Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course. [ Time Frame: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months). ]
    The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a probable or culture confirmed ID) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.

  6. Person Year Rate in the Prevention of Probable or Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course. [ Time Frame: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months). ]
    The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a probable or culture confirmed ID) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.

  7. Person Year Rate in the Prevention of Probable or Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 7-11 Months Schedule. [ Time Frame: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months). ]
    The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a probable or culture confirmed ID) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.

  8. Person Year Rate in the Prevention of Probable or Culture-confirmed Invasive Disease (ID)- In Children Starting Vaccination in the 12-18 Months Schedule. [ Time Frame: Period of follow-up was any time after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (The blinded ID Follow-up period lasted at least 30 months). ]
    The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a probable or culture confirmed ID) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.

  9. Person Year Rate in Reducing Hospital-diagnosed Pneumonia- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course. [ Time Frame: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=24 months. ]
    PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. Hospital-diagnosed pneumonia (HDP) cases identified based on hospital discharge diagnosis using international Classification of Disease (ICD)-10 diagnosis codes: J10.0 (Influenza with HDP, other influenza virus identified), J11.0 (Influenza with HDP, virus not identified), J12 (Viral HDP, not elsewhere classified), J13 (HDP due to Sp.), J14 (for HDP due to Hi.), J15 (all HDP, not elsewhere classified), J16 (HDP due to other infectious organisms, not elsewhere classified), J17 (HDP in diseases classified elsewhere), J18 (HDP organism unspecified), J85.1 (Abscess of lung with HDP), and J86 (Pyothorax including empyema).

  10. Person Year Rate in Reducing Hospital-diagnosed Pneumonia - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course. [ Time Frame: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=24 months. ]
    PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. Hospital-diagnosed pneumonia (HDP) cases identified based on hospital discharge diagnosis using international Classification of Disease (ICD)-10 diagnosis codes: J10.0 (Influenza with HDP, other influenza virus identified), J11.0 (Influenza with HDP, virus not identified), J12 (Viral HDP, not elsewhere classified), J13 (HDP due to Sp.), J14 (for HDP due to Hi.), J15 (all HDP, not elsewhere classified), J16 (HDP due to other infectious organisms, not elsewhere classified), J17 (HDP in diseases classified elsewhere), J18 (HDP organism unspecified), J85.1 (Abscess of lung with HDP), and J86 (Pyothorax including empyema).

  11. Person Year Rate in Reducing Hospital-diagnosed Pneumonia- In Children Starting Vaccination in the 7-11 Months Schedule. [ Time Frame: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=27 months. ]
    PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. Hospital-diagnosed pneumonia (HDP) cases identified based on hospital discharge diagnosis using international Classification of Disease (ICD)-10 diagnosis codes: J10.0 (Influenza with HDP, other influenza virus identified), J11.0 (Influenza with HDP, virus not identified), J12 (Viral HDP, not elsewhere classified), J13 (HDP due to Sp.), J14 (for HDP due to Hi.), J15 (all HDP, not elsewhere classified), J16 (HDP due to other infectious organisms, not elsewhere classified), J17 (HDP in diseases classified elsewhere), J18 (HDP organism unspecified), J85.1 (Abscess of lung with HDP), and J86 (Pyothorax including empyema).

  12. Person Year Rate in Reducing Hospital-diagnosed Pneumonia - In Children Starting Vaccination in the 12-18 Months Schedule. [ Time Frame: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=27 months. ]
    PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. Hospital-diagnosed pneumonia (HDP) cases identified based on hospital discharge diagnosis using international Classification of Disease (ICD)-10 diagnosis codes: J10.0 (Influenza with HDP, other influenza virus identified), J11.0 (Influenza with HDP, virus not identified), J12 (Viral HDP, not elsewhere classified), J13 (HDP due to Sp.), J14 (for HDP due to Hi.), J15 (all HDP, not elsewhere classified), J16 (HDP due to other infectious organisms, not elsewhere classified), J17 (HDP in diseases classified elsewhere), J18 (HDP organism unspecified), J85.1 (Abscess of lung with HDP), and J86 (Pyothorax including empyema).

  13. Person Year Rate in Reducing Hospital-diagnosed Pneumonia With Chest X-ray (CXR) Reading According to WHO Criteria- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course. [ Time Frame: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=24 months. ]
    PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia [HDP]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata for non-consolidated HDP and without strata for consolidated HDP). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. CXR HDP was defined as a HDP case with the presence of abnormal pulmonary infiltrates on the CXR as per independent review panel judgement using WHO methodology. Abnormal pulmonary infiltrates could be either with (Consolidated HDP) or without (Non-consolidated HDP) alveolar consolidation/pleural effusion. New cases of HDP and CXR HDP were based on a 30-day rule, i.e. a new episode was considered if at least a 30-day interval elapsed from the onset of the previous episode.

  14. Person Year Rate in Reducing Hospital-diagnosed Pneumonia With CXR Reading According to WHO Criteria - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course. [ Time Frame: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=24 months. ]
    PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia [HDP]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata for non-consolidated HDP and without strata for consolidated HDP). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. CXR HDP was defined as a HDP case with the presence of abnormal pulmonary infiltrates on the CXR as per independent review panel judgement using WHO methodology. Abnormal pulmonary infiltrates could be either with (Consolidated HDP) or without (Non-consolidated HDP) alveolar consolidation/pleural effusion. New cases of HDP and CXR HDP were based on a 30-day rule, i.e. a new episode was considered if at least a 30-day interval elapsed from the onset of the previous episode.

  15. Person Year Rate in Reducing Hospital-diagnosed Pneumonia With CXR Reading According to WHO Criteria - In Children Starting Vaccination in the 7-11 Months Schedule. [ Time Frame: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=27 months. ]
    PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia [HDP]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata for non-consolidated HDP and without strata for consolidated HDP). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. CXR HDP was defined as a HDP case with the presence of abnormal pulmonary infiltrates on the CXR as per independent review panel judgement using WHO methodology. Abnormal pulmonary infiltrates could be either with (Consolidated HDP) or without (Non-consolidated HDP) alveolar consolidation/pleural effusion. New cases of HDP and CXR HDP were based on a 30-day rule, i.e. a new episode was considered if at least a 30-day interval elapsed from the onset of the previous episode.

  16. Person Year Rate in Reducing Hospital-diagnosed Pneumonia With CXR Reading According to WHO Criteria - In Children Starting Vaccination in the 12-18 Months Schedule. [ Time Frame: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=27 months. ]
    PYAR was calculated: n (= number of subjects with hospital-diagnosed pneumonia [HDP]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata for non-consolidated HDP and without strata for consolidated HDP). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. CXR HDP was defined as a HDP case with the presence of abnormal pulmonary infiltrates on the CXR as per independent review panel judgement using WHO methodology. Abnormal pulmonary infiltrates could be either with (Consolidated HDP) or without (Non-consolidated HDP) alveolar consolidation/pleural effusion. New cases of HDP and CXR HDP were based on a 30-day rule, i.e. a new episode was considered if at least a 30-day interval elapsed from the onset of the previous episode.

  17. Person Year Rate in Prevention of All Tympanostomy Tube Placements- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course. [ Time Frame: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=24 months. ]
    PYAR was calculated: n (= number of subjects with tympanostomy tube placement[TTP]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. A TTP episode was defined as a TTP episode classified under the DCA 20 code in the Finnish National Institute of Health and Welfare (THL) and Social Insurance Institution of Finland (KELA) registers, using the Nordic Centre for Classifications in Health Care (NOMESCO) Classification of Surgical Procedures (NCSP), version 1.12 from January 2008, and could refer to either an unilateral or a bilateral TTP procedure. New episodes of TTP defined according to a 30-day rule meaning that a new episode was considered if at least 30-day interval elapsed from the onset of the previous episode.

  18. Person Year Rate in Prevention of All Tympanostomy Tube Placements - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course. [ Time Frame: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=24 months. ]
    PYAR was calculated: n (= number of subjects with tympanostomy tube placement[TTP]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. A TTP episode was defined as a TTP episode classified under the DCA 20 code in the Finnish National Institute of Health and Welfare (THL) and Social Insurance Institution of Finland (KELA) registers, using the Nordic Centre for Classifications in Health Care (NOMESCO) Classification of Surgical Procedures (NCSP), version 1.12 from January 2008, and could refer to either an unilateral or a bilateral TTP procedure. New episodes of TTP defined according to a 30-day rule meaning that a new episode was considered if at least 30-day interval elapsed from the onset of the previous episode.

  19. Person Year Rate in Prevention of All Tympanostomy Tube Placements - In Children Starting Vaccination in the 7-11 Months Schedule. [ Time Frame: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=27 months. ]
    PYAR was calculated: n (= number of subjects with tympanostomy tube placement[TTP]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. A TTP episode was defined as a TTP episode classified under the DCA 20 code in the Finnish National Institute of Health and Welfare (THL) and Social Insurance Institution of Finland (KELA) registers, using the Nordic Centre for Classifications in Health Care (NOMESCO) Classification of Surgical Procedures (NCSP), version 1.12 from January 2008, and could refer to either an unilateral or a bilateral TTP procedure. New episodes of TTP defined according to a 30-day rule meaning that a new episode was considered if at least 30-day interval elapsed from the onset of the previous episode.

  20. Person Year Rate in Prevention of All Tympanostomy Tube Placements - In Children Starting Vaccination in the 12-18 Months Schedule. [ Time Frame: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=27 months. ]
    PYAR was calculated: n (= number of subjects with tympanostomy tube placement[TTP]) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. A TTP episode was defined as a TTP episode classified under the DCA 20 code in the Finnish National Institute of Health and Welfare (THL) and Social Insurance Institution of Finland (KELA) registers, using the Nordic Centre for Classifications in Health Care (NOMESCO) Classification of Surgical Procedures (NCSP), version 1.12 from January 2008, and could refer to either an unilateral or a bilateral TTP procedure. New episodes of TTP defined according to a 30-day rule meaning that a new episode was considered if at least 30-day interval elapsed from the onset of the previous episode.

  21. Person Year Rate in Prevention of All Antimicrobial Prescriptions- In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course. [ Time Frame: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=24 months. ]
    PYAR was calculated: n (= number of subjects with antimicrobial prescriptions (APs)) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. An APs episode was an episode of APs to an infant/child falling under following Anatomic Therapeutic Chemical [ATC] codes: J01 (APs) and following codes for AP usually recommended for otitis media (OM) and respiratory tract infections (RTI). "For OM and RTI" category corresponds to following definition: APs for antibacterial usually recommended for OM and RTI (ATC codes: J01CA04, J01CR02, J01CE02, J01DC02, J01DC04, J01EE02, J01FA09 and J01FA10). New episodes of APs were analyzed according to a 2-day rule meaning new episode considered if at least 2 day interval elapsed from the onset of the previous episode.

  22. Person Year Rate in Prevention of All Antimicrobial Prescriptions - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course. [ Time Frame: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=24 months. ]
    PYAR was calculated: n (= number of subjects with antimicrobial prescriptions (APs)) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. An APs episode was an episode of APs to an infant/child falling under following Anatomic Therapeutic Chemical [ATC] codes: J01 (APs) and following codes for AP usually recommended for otitis media (OM) and respiratory tract infections (RTI). "For OM and RTI" category corresponds to following definition: APs for antibacterial usually recommended for OM and RTI (ATC codes: J01CA04, J01CR02, J01CE02, J01DC02, J01DC04, J01EE02, J01FA09 and J01FA10). New episodes of APs were analyzed according to a 2-day rule meaning new episode considered if at least 2 day interval elapsed from the onset of the previous episode.

  23. Person Year Rate in Prevention of All Antimicrobial Prescriptions - In Children Starting Vaccination in the 7-11 Months Schedule. [ Time Frame: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=27 months. ]
    PYAR was calculated: n (= number of subjects with antimicrobial prescriptions (APs)) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. An APs episode was an episode of APs to an infant/child falling under following Anatomic Therapeutic Chemical [ATC] codes: J01 (APs) and following codes for AP usually recommended for otitis media (OM) and respiratory tract infections (RTI). "For OM and RTI" category corresponds to following definition: APs for antibacterial usually recommended for OM and RTI (ATC codes: J01CA04, J01CR02, J01CE02, J01DC02, J01DC04, J01EE02, J01FA09 and J01FA10). New episodes of APs were analyzed according to a 2-day rule meaning new episode considered if at least 2 day interval elapsed from the onset of the previous episode.

  24. Person Year Rate in Prevention of All Antimicrobial Prescriptions - In Children Starting Vaccination in the 12-18 Months Schedule. [ Time Frame: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - FU mean time=27 months. ]
    PYAR was calculated: n (= number of subjects with antimicrobial prescriptions (APs)) divided by T (= sum of follow-up (FU) period expressed in years) (per 1000) with 95% CI (2-sided profile log-likelihood ratio 95% CI-classical log linear Poisson regression with strata). FU period considered as period between Dose 1 administration and cut-off date of 31 December 2011. An APs episode was an episode of APs to an infant/child falling under following Anatomic Therapeutic Chemical [ATC] codes: J01 (APs) and following codes for AP usually recommended for otitis media (OM) and respiratory tract infections (RTI). "For OM and RTI" category corresponds to following definition: APs for antibacterial usually recommended for OM and RTI (ATC codes: J01CA04, J01CR02, J01CE02, J01DC02, J01DC04, J01EE02, J01FA09 and J01FA10). New episodes of APs were analyzed according to a 2-day rule meaning new episode considered if at least 2 day interval elapsed from the onset of the previous episode.

  25. Number of Subjects Classified by Antimicrobial Susceptiblity of IPD Isolates in Children Starting Vaccination Within 7 Months of Life and Assigned to a 2 or 3-dose Primary Vaccination Course [ Time Frame: Period of follow-up was any time after the administration of first vaccine dose till the end date of the follow-up (31 December 2011) - mean FU time=24 months. ]
    Antimicrobial susceptibility classification of IPD isolates reported during IPD follow-up with percentages for each serotype for the following categories: S= susceptible; I = intermediate ; R = resistant; N = not available.

  26. Number of Subjects With Lower Respiratory Tract Infections (LRTIs) (in a Subset of 1500 Subjects in Turku Area ) [ Time Frame: From the administration of the first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (at least 30 months). ]
    Analysis of this outcome in the Turku area was not performed as no data was collected related to LRTIs.

  27. Number of Subjects With Upper Respiratory Tract Infections (URTIs) (in a Subset of 1500 Subjects in Turku Area). [ Time Frame: From the administration of the first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (at least 30 months). ]
    Analysis of this outcome in the Turku area was not performed as no data was collected related to URTIs.

  28. Number of Subjects With Any and Grade 3 Solicited Local Symptoms. [ Time Frame: Within 4 days (4D) after each vaccination (M0+4D, M1+4D [only for 3+1 schedule], M2+4D, M8+4D [booster dose] for 6W-6M subjects; M0+4D, M2+4D, M6+4D [booster dose] for 7M-11M subjects; M0+4D, M6+4D for 12M-18M subjects) ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.

  29. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. [ Time Frame: Within 4 days (4D) after each vaccination (M0+4D, M1+4D [only for 3+1 schedule], M2+4D, M8+4D [booster dose] for 6W-6M subjects; M0+4D, M2+4D, M6+4D [booster dose] for 7M-11M subjects; M0+4D, M6+4D for 12M-18M subjects) ]
    Assessed solicited general symptoms were drowsiness, fever [defined as rectal temperature ≥ 38 degrees Celsius (°C) or oral/axillary/tympanic temperature equal to or above 37.5°C], irritability/fussiness and loss pf appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = rectal temperature > 40°C. Grade 3 irritability/fussiness = cried that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = a symptom assessed by investigator as causally related to the vaccination.

  30. Number of Subjects With Any Unsolicited Adverse Events (AEs). [ Time Frame: Within 31 days (31D) after each vaccination (M0+31D, M1+31D [only for 3+1 schedule], M2+31D, M8+31D [booster dose] for 6W-6M subjects; M0+31D, M2+31D, M6+31D [booster dose] for 7M-11M subjects; M0+31D, M6+31D for 12M-18M subjects) ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

  31. Number of Subjects With Serious Adverse Events (SAEs). [ Time Frame: Following administration of the first vaccine dose up to study end (M0 up to M18 for subjects aged 6W to 6M at enrollment; M0 up to M16 for subjects aged 7M to 11M at enrollment; M0 up to M9 for subjects aged 12M to 18M at enrollment) ]
    An event is defined as 'serious' when it meets one of the pre-defined outcomes described below: results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation; results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. Medical or scientific judgement should be exercised in deciding whether reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. These should also be considered serious.

  32. Number of Subjects Enrolled and Vaccinated in the 10PN-PD-DIT-043 and 10PN-PD-DIT-053 Study With Post-study SAEs Reported Via Passive Surveillance- Subjects Enrolled Aged 6 Weeks to 6 Months and 7 to 18 Months [ Time Frame: From the end of the blinded ID Follow-Up period (at least 30 months from the study start) up to the end of 18-month period after study unblinding ]
    An event is defined as 'serious' when it meets one of the pre-defined outcomes described below: results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation; results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. Medical or scientific judgement should be exercised in deciding whether reporting is appropriate in other situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalisation but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. These should also be considered serious.

  33. NUMBER OF NASOPHARYNGEAL SWABS WITH STREPTOCOCCUS PNEUMONIAE PATHOGENS (S. PN.), ANY PATHOGEN. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN [ Time Frame: At 3 months (mths) of age (prior to dose 1); at 6 mths of age (1 mth post dose 3 or post dose 2); at 11-12 mths of age (pre-booster dose); at 14-15 mths of age (3 mths post-booster); at 18-22 mths of age (10 mths post-booster) ]
    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated. The "prior to dose 1" nasopharyngeal swab samples collected from subjects within their first 7 months of age were obtained solely from the Immuno subset (The Immuno subset was constituted of the first +/- 1500 subjects from whom blood samples were collected, according to age and treatment groups).

  34. NUMBER OF NASOPHARYNGEAL SWABS WITH STREPTOCOCCUS PNEUMONIAE PATHOGENS (S. PN.), ANY PATHOGEN. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN [ Time Frame: At 7-11 months (mths) of age (prior to dose 1); at 9-13 mths of age (1 mth post dose 2); at 13-17 mths of age (pre-booster dose); at 16-20 mths of age (3 mths post-booster); at 23-27 mths of age (10 mths post-booster) ]
    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated.

  35. NUMBER OF NASOPHARYNGEAL SWABS WITH STREPTOCOCCUS PNEUMONIAE PATHOGENS (S. PN.), ANY PATHOGEN. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN [ Time Frame: At 12-18 months (mths) of age (prior to dose 1); at 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2) ]
    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated.

  36. NUMBER OF NASOPHARYNGEAL SWABS WITH STREPTOCOCCUS PNEUMONIAE (S. PN.) VACCINE SEROTYPES. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN [ Time Frame: At 3 months (mths) of age (prior to dose 1); at 6 mths of age (1 mth post dose 3 or post dose 2); at 11-12 mths of age (pre-booster dose); at 14-15 mths of age (3 mths post-booster); at 18-22 mths of age (10 mths post-booster) ]
    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated. The "prior to dose 1" nasopharyngeal swab samples collected from subjects within their first 7 months of age were obtained solely from the Immuno subset (The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups).

  37. NUMBER OF NASOPHARYNGEAL SWABS WITH STREPTOCOCCUS PNEUMONIAE (S. PN.) VACCINE SEROTYPES. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN [ Time Frame: At 7-11 months (mths) of age (prior to dose 1); at 9-13 mths of age (1 mth post dose 2); at 13-17 mths of age (pre-booster dose); at 16-20 mths of age (3 mths post-booster); at 23-27 mths of age (10 mths post-booster) ]
    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated.

  38. NUMBER OF NASOPHARYNGEAL SWABS WITH STREPTOCOCCUS PNEUMONIAE (S. PN.) VACCINE SEROTYPES. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN [ Time Frame: At 12-18 months (mths) of age (prior to dose 1); at 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2) ]
    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated.

  39. NUMBER OF SUBJECTS WITH ACQUISITION OF NEW STREPTOCOCCUS PNEUMONIAE (S. PN.) STRAINS, ANY PATHOGEN, IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN [ Time Frame: At 11-12 mths of age (pre-booster dose); at 14-15 mths of age (3 mths post-booster); at 18-22 mths of age (10 mths post-booster) ]
    At each time point where a swab sample result was available, the number/percentage of subjects with new acquisition associated to the specified bacteria at the considered time point was tabulated.

  40. NUMBER OF SUBJECTS WITH ACQUISITION OF NEW STREPTOCOCCUS PNEUMONIAE (S. PN.) STRAINS, ANY PATHOGEN, IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN [ Time Frame: At 9-13 mths of age (1 mth post dose 2); at 13-17 mths of age (pre-booster dose); at 16-20 mths of age (3 mths post-booster); at 23-27 mths of age (10 mths post-booster) ]
    At each time point where a swab sample result was available, the number/percentage of subjects with new acquisition associated to the specified bacteria at the considered time point was tabulated.

  41. NUMBER OF SUBJECTS WITH ACQUISITION OF NEW STREPTOCOCCUS PNEUMONIAE (S. PN.) STRAINS, ANY PATHOGEN, IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN [ Time Frame: At 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2) ]
    At each time point where a swab sample result was available, the number/percentage of subjects with new acquisition associated to the specified bacteria at the considered time point was tabulated.

  42. NUMBER OF SUBJECTS WITH ACQUISITION OF NEW STREPTOCOCCUS PNEUMONIAE (S. PN.) VACCINE SEROTYPE STRAINS, IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN [ Time Frame: At 11-12 mths of age (pre-booster dose); at 14-15 mths of age (3 mths post-booster); at 18-22 mths of age (10 mths post-booster) ]
    At each time point where a swab sample result was available, the number/percentage of subjects with new acquisition associated to the specified bacteria at the considered time point was tabulated.

  43. NUMBER OF SUBJECTS WITH ACQUISITION OF NEW STREPTOCOCCUS PNEUMONIAE (S. PN.) VACCINE SEROTYPE STRAINS, IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN [ Time Frame: At 9-13 mths of age (1 mth post dose 2); at 13-17 mths of age (pre-booster dose); at 16-20 mths of age (3 mths post-booster); at 23-27 mths of age (10 mths post-booster) ]
    At each time point where a swab sample result was available, the number/percentage of subjects with new acquisition associated to the specified bacteria at the considered time point was tabulated.

  44. NUMBER OF SUBJECTS WITH ACQUISITION OF NEW STREPTOCOCCUS PNEUMONIAE (S. PN.) VACCINE SEROTYPE STRAINS, IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN [ Time Frame: At 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2) ]
    At each time point where a swab sample result was available, the number/percentage of subjects with new acquisition associated to the specified bacteria at the considered time point was tabulated.

  45. NUMBER OF NASOPHARYNGEAL SWABS WITH HAEMOPHILUS INFLUENZAE (H. INFL.) PATHOGENS. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN [ Time Frame: At 3 months (mths) of age (prior to dose 1); at 6 mths of age (1 mth post dose 3 or post dose 2); at 11-12 mths of age (pre-booster dose); at 14-15 mths of age (3 mths post-booster); at 18-22 mths of age (10 mths post-booster) ]
    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated. The "prior to dose 1" nasopharyngeal swab samples collected from subjects within their first 7 months of age were obtained solely from the Immuno subset (The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups). Data presented only include results from samples confirmed as positive for Hi/NTHi after differentiation from H. haemolyticus by PCR assay.

  46. NUMBER OF NASOPHARYNGEAL SWABS WITH HAEMOPHILUS INFLUENZAE (H. INFL.) PATHOGENS. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN [ Time Frame: At 7-11 months (mths) of age (prior to dose 1); at 9-13 mths of age (1 mth post dose 2); at 13-17 mths of age (pre-booster dose); at 16-20 mths of age (3 mths post-booster); at 23-27 mths of age (10 mths post-booster) ]
    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated. Data presented only include results from samples confirmed as positive for Hi /NTHi after differentiation from H. haemolyticus by PCR assay.

  47. NUMBER OF NASOPHARYNGEAL SWABS WITH HAEMOPHILUS INFLUENZAE (H. INFL.) PATHOGENS. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN [ Time Frame: At 12-18 months (mths) of age (prior to dose 1); at 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2) ]
    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated. Data presented only include results from samples confirmed as positive for Hi/NTHi after differentiation from H. haemolyticus by PCR assay.

  48. NUMBER OF SUBJECTS WITH ACQUISITION OF NEW HAEMOPHILUS INFLUENZAE (H. INFL.) PATHOGENS IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN [ Time Frame: At 11-12 mths of age (pre-booster dose) ; at 14-15 mths of age ( 3 mths post-booster) ; at 18-22 mths of age (10 mths post-booster) ]
    At each time point where a swab sample result was available, the number/percentage of subjects with new acquisition associated to the specified bacteria at the considered time point was tabulated. Data presented only include results from samples confirmed as positive for Hi/NTHi after differentiation from H. haemolyticus by PCR assay.

  49. NUMBER OF SUBJECTS WITH ACQUISITION OF NEW HAEMOPHILUS INFLUENZAE (H. INFL.) PATHOGENS IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN [ Time Frame: At 9-13 mths of age (1 mth post dose 2); at 13-17 mths of age (pre-booster dose); at 16-20 mths of age (3 mths post-booster) at 23-27 mths of age (10 mths post-booster) ]
    At each time point where a swab sample result was available, the number/percentage of subjects with new acquisition associated to the specified bacteria at the considered time point was tabulated. Data presented only include results from samples confirmed as positive for Hi/NTHi after differentiation from H. haemolyticus by PCR assay.

  50. NUMBER OF SUBJECTS WITH ACQUISITION OF NEW HAEMOPHILUS INFLUENZAE (H. INFL.) PATHOGENS IDENTIFIED IN NASOPHARYNGEAL SWABS. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN [ Time Frame: At 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2) ]
    At each time point where a swab sample result was available, the number/percentage of subjects with new acquisition associated to the specified bacteria at the considered time point was tabulated. Data presented only include results from samples confirmed as positive for Hi/NTHi after differentiation from H. haemolyticus by PCR assay.

  51. NUMBER OF NASOPHARYNGEAL SWABS WITH MORAXELLA CATARRHALIS PATHOGENS. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN [ Time Frame: At 3 months (mths) of age (prior to dose 1); at 6 mths of age (1 mth post dose 3 or post dose 2); at 11-12 mths of age (pre-booster dose); at 14-15 mths of age (3 mths post-booster); at 18-22 mths of age (10 mths post-booster) ]
    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated. The "prior to dose 1" nasopharyngeal swab samples collected from subjects within their first 7 months of age were obtained solely from the Immuno subset (The Immuno subset was constituted of the first 1500 subjects from whom blood samples were collected, according to age and treatment groups).

  52. NUMBER OF NASOPHARYNGEAL SWABS WITH MORAXELLA CATARRHALIS PATHOGENS. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN [ Time Frame: At 7-11 months (mths) of age (prior to dose 1); at 9-13 mths of age (1 mth post dose 2) ; at 13-17 mths of age (pre-booster dose) ; at 16-20 mths of age ( 3 mths post-booster) ; at 23-27 mths of age (10 mths post-booster) ]
    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated.

  53. NUMBER OF NASOPHARYNGEAL SWABS WITH MORAXELLA CATARRHALIS PATHOGENS. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN [ Time Frame: At 12-18 months (mths) of age (prior to dose 1); at 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2) ]
    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated.

  54. NUMBER OF NASOPHARYNGEAL SWABS WITH GROUP A STREPTOCOCCUS PATHOGENS. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN [ Time Frame: At 3 months (mths) of age (prior to dose 1); at 6 mths of age (1 mth post dose 3 or post dose 2) ; at 11-12 mths of age (pre-booster dose) ; at 14-15 mths of age ( 3 mths post-booster) ; at 18-22 mths of age (10 mths post-booster) ]
    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated. The "prior to dose 1" nasopharyngeal swab samples collected from subjects within their first 7 months of age were obtained solely from the Immuno subset (The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups).

  55. NUMBER OF NASOPHARYNGEAL SWABS WITH GROUP A STREPTOCOCCUS PATHOGENS. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN [ Time Frame: At 7-11 months (mths) of age (prior to dose 1); at 9-13 mths of age (1 mth post dose 2) ; at 13-17 mths of age (pre-booster dose) ; at 16-20 mths of age ( 3 mths post-booster) ; at 23-27 mths of age (10 mths post-booster) ]
    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated.

  56. NUMBER OF NASOPHARYNGEAL SWABS WITH GROUP A STREPTOCOCCUS PATHOGENS. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN [ Time Frame: At 12-18 months (mths) of age (prior to dose 1); at 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2) ]
    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated.

  57. NUMBER OF NASOPHARYNGEAL SWABS WITH STAPHYLOCOCCUS AUREUS PATHOGENS. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN [ Time Frame: At 3 months (mths) of age (prior to dose 1); at 6 mths of age (1 mth post dose 3 or post dose 2) ; at 11-12 mths of age (pre-booster dose) ; at 14-15 mths of age ( 3 mths post-booster) ; at 18-22 mths of age (10 mths post-booster) ]
    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated. The "prior to dose 1" nasopharyngeal swab samples collected from subjects within their first 7 months of age were obtained solely from the Immuno subset (The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups).

  58. NUMBER OF NASOPHARYNGEAL SWABS WITH STAPHYLOCOCCUS AUREUS PATHOGENS. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN [ Time Frame: At 7-11 months (mths) of age (prior to dose 1); at 9-13 mths of age (1 mth post dose 2) ; at 13-17 mths of age (pre-booster dose) ; at 16-20 mths of age ( 3 mths post-booster) ; at 23-27 mths of age (10 mths post-booster) ]
    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated.

  59. NUMBER OF NASOPHARYNGEAL SWABS WITH STAPHYLOCOCCUS AUREUS PATHOGENS. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN [ Time Frame: At 12-18 months (mths) of age (prior to dose 1); at 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2) ]
    At each time point where a swab sample result was available, the number/percentage of swabs associated with the specified bacteria was tabulated.

  60. PNEUMOCOCCAL ANTIBODY CONCENTRATIONS AGAINST PNEUMOCOCCAL VACCINE SEROTYPES, IN THE IMMUNO SUBSET, IN SUBJECTS RECEIVING 3+1 INFANT SCHEDULES OF 10PN [ Time Frame: At 6 mths of age (1 mth post dose 3); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster) ]
    Antibody concentrations were measured by 22F -inhibition enzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was >= 0.05 µg/mL. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.

  61. PNEUMOCOCCAL ANTIBODY CONCENTRATIONS AGAINST PNEUMOCOCCAL VACCINE SEROTYPES, IN THE IMMUNO SUBSET, IN SUBJECTS RECEIVING 2+1 INFANT SCHEDULES OF 10PN [ Time Frame: At 6 mths of age (1 mth post dose 2); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster) ]
    Antibody concentrations were measured by 22F-inhibition enzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was >= 0.05 µg/mL. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.

  62. PNEUMOCOCCAL ANTIBODY CONCENTRATIONS AGAINST CROSS-REACTIVE PNEUMOCOCCAL SEROTYPES 6A AND 19A, IN THE IMMUNO SUBSET, IN SUBJECTS RECEIVING 3+1 INFANT SCHEDULES OF 10PN [ Time Frame: At 6 mths of age (1 mth post dose 3); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster) ]
    Antibody concentrations were measured by 22F-inhibitionenzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the cross-reactive pneumococcal serotypes 6A and 19A. The cut-off of the assay was >= 0.05 µg/mL. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.

  63. PNEUMOCOCCAL ANTIBODY CONCENTRATIONS AGAINST CROSS-REACTIVE PNEUMOCOCCAL SEROTYPES 6A AND 19A, IN THE IMMUNO SUBSET, IN SUBJECTS RECEIVING 2+1 INFANT SCHEDULES OF 10PN [ Time Frame: At 6 mths of age (1 mth post dose 2); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster) ]
    Antibody concentrations were measured by 22F-inhibitionenzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the cross-reactive pneumococcal serotypes 6A and 19A. The cut-off of the assay was >= 0.05 µg/mL. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.

  64. TITERS FOR OPSONOPHAGOCYTIC ACTIVITY AGAINST VACCINE PNEUMOCOCCAL SEROTYPES, IN THE IMMUNO SUBSET, IN SUBJECTS RECEIVING 3+1 INFANT SCHEDULES OF 10PN [ Time Frame: At 6 mths of age (1 mth post dose 3); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster) ]
    Titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was >= 8. The Immuno subset was constituted of the ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.

  65. TITERS FOR OPSONOPHAGOCYTIC ACTIVITY AGAINST VACCINE PNEUMOCOCCAL SEROTYPES, IN THE IMMUNO SUBSET, IN SUBJECTS RECEIVING 2+1 INFANT SCHEDULES OF 10PN [ Time Frame: At 6 mths of age (1 mth post dose 2); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster) ]
    Titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was >= 8. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.

  66. TITERS FOR OPSONOPHAGOCYTIC ACTIVITY AGAINST CROSS-REACTIVE PNEUMOCOCCAL SEROTYPES 6A AND 19A, IN THE IMMUNO SUBSET. IN SUBJECTS RECEIVING 3+1 INFANT SCHEDULES OF 10PN [ Time Frame: At 6 mths of age (1 mth post dose 3); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster) ]
    Titers for opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A. The cut-off of the assay was >= 8. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.

  67. TITERS FOR OPSONOPHAGOCYTIC ACTIVITY AGAINST CROSS-REACTIVE PNEUMOCOCCAL SEROTYPES 6A AND 19A, IN THE IMMUNO SUBSET. IN SUBJECTS RECEIVING 2+1 INFANT SCHEDULES OF 10PN [ Time Frame: At 6 mths of age (1 mth post dose 2); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster) ]
    Titers for opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A. The cut-off of the assay was >= 8. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.

  68. ANTIBODY CONCENTRATIONS AGAINST PROTEIN D (ANTI-PD), IN THE IMMUNO SUBSET. IN SUBJECTS RECEIVING 3+1 INFANT SCHEDULES OF 10PN [ Time Frame: At 6 mths of age (1 mth post dose 3); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster) ]
    ANTI-PD concentrations are expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). The cut-off of the assay was >= 100 EL.U/mL. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.

  69. ANTIBODY CONCENTRATIONS AGAINST PROTEIN D(ANTI-PD), IN THE IMMUNO SUBSET. IN SUBJECTS RECEIVING 2+1 INFANT SCHEDULES OF 10PN [ Time Frame: At 6 mths of age (1 mth post dose 2); at 11-12 mths of age (pre-booster dose) ; at 12-13 mths of age ( 1 mth post-booster) ; at 18-22 mths of age (10 mths post-booster) ]
    ANTI-PD concentrations are expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). The cut-off of the assay was >= 100 EL.U/mL. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.

  70. PNEUMOCOCCAL ANTIBODY CONCENTRATIONS AGAINST PNEUMOCOCCAL VACCINE SEROTYPES, IN THE IMMUNO SUBSET. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN [ Time Frame: At 8-12 months (mths) of age (1 mth post dose 1); at 9-13 mths of age (1 mth post dose 2) ; at 13-17 mths of age (pre-booster dose) ; at 14-18 mths of age ( 1 mths post-booster) ; at 23-27 mths of age (10 mths post-booster) ]
    Antibody concentrations were measured by 22F-inhibitionenzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was >= 0.05 µg/mL. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.

  71. PNEUMOCOCCAL ANTIBODY CONCENTRATIONS AGAINST PNEUMOCOCCAL VACCINE SEROTYPES, IN THE IMMUNO SUBSET. IN SUBJECTS RECEIVING RECEIVING 12-18M SCHEDULE OF 10PN [ Time Frame: At 13-19 months (mths) of age (1 mth post dose 1); at 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2) ]
    Antibody concentrations were measured by 22F-inhibitionenzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was >= 0.05 µg/mL. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.

  72. PNEUMOCOCCAL ANTIBODY CONCENTRATIONS AGAINST CROSS-REACTIVE PNEUMOCOCCAL SEROTYPES, IN THE IMMUNO SUBSET. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN [ Time Frame: At 8-12 months (mths) of age (1 mth post dose 1); at 9-13 mths of age (1 mth post dose 2) ; at 13-17 mths of age (pre-booster dose) ; at 14-18 mths of age ( 1 mths post-booster) ; at 23-27 mths of age (10 mths post-booster) ]
    Antibody concentrations were measured by 22F-inhibitionenzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the cross-reactive pneumococcal serotypes 6A and 19A. The cut-off of the assay was >= 0.05 µg/mL. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.

  73. PNEUMOCOCCAL ANTIBODY CONCENTRATIONS AGAINST CROSS-REACTIVE PNEUMOCOCCAL SEROTYPES, IN THE IMMUNO SUBSET. IN SUBJECTS RECEIVING RECEIVING 12-18M SCHEDULE OF 10PN [ Time Frame: At 13-19 months (mths) of age (1 mth post dose 1); at 19-25 mths of age (1 mth post dose 2); at 21-27 mths of age (3 months post dose 2) ]
    Antibody concentrations were measured by 22F-inhibitionenzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the cross-reactive pneumococcal serotypes 6A and 19A. The cut-off of the assay was >= 0.05 µg/mL. The Immuno subset was constituted of the first ± 1500 subjects from whom blood samples were collected, according to age and treatment groups.

  74. PERSON YEAR RATE AS REGARDS SUBJECTS WITH ACUTE OTITIS MEDIA (AOM) EPISODE ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN [ Time Frame: Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) follow-up period (31 January 2012). ]
    The PYAR (Person-Year Rate) as regards subjects with AOM episode was tabulated. PYAR was calculated as follows n (= number of subjects reported with event) divided by T (= sum of follow-up period expressed in years) (per 1000). An AOM episode assessed as with level 1 of diagnostic certainty was defined as an AOM event diagnosed by a physician according to the Finnish AOM management guidelines (confirmed cases) and reported by subjects' parent(s)/guardian(s) regardless the documentation in medical records or other source document. Note that a post-hoc re-analysis of AOM endpoints with a corrected definition of follow-up taking into account individual end of follow-up time was performed; the results of re-analysis as the most prominent for AOM outcome are presented in this summary.

  75. PERSON YEAR RATE AS REGARDS SUBJECTS WITH ACUTE OTITIS MEDIA (AOM) EPISODE ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN [ Time Frame: Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (31 January 2012). ]
    The PYAR (Person-Year Rate) as regards subjects with AOM episode was tabulated. PYAR was calculated as follows n (= number of subjects reported with event) divided by T (= sum of follow-up period expressed in years) (per 1000). An AOM episode assessed as with level 1 of diagnostic certainty was defined as an AOM event diagnosed by a physician according to the Finnish AOM management guidelines (confirmed cases) and reported by subjects' parent(s)/guardian(s) regardless the documentation in medical records or other source document. Note that a post-hoc re-analysis of AOM endpoints with a corrected definition of follow-up taking into account individual end of follow-up time was performed; the results of re-analysis as the most prominent for AOM outcome are presented in this summary.

  76. PERSON YEAR RATE AS REGARDS SUBJECTS WITH ACUTE OTITIS MEDIA (AOM) EPISODE ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN [ Time Frame: Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (31 January 2012). ]
    The PYAR (Person-Year Rate) as regards subjects with AOM episode was tabulated. PYAR was calculated as follows n (= number of subjects reported with event) divided by T (= sum of follow-up period expressed in years) (per 1000). An AOM episode assessed as with level 1 of diagnostic certainty was defined as an AOM event diagnosed by a physician according to the Finnish AOM management guidelines (confirmed cases) and reported by subjects' parent(s)/guardian(s) regardless the documentation in medical records or other source document. Note that a post-hoc re-analysis of AOM endpoints with a corrected definition of follow-up taking into account individual end of follow-up time was performed; the results of re-analysis as the most prominent for AOM outcome are presented in this summary.

  77. PERSON YEAR RATE AS REGARDS SUBJECTS WITH RECURRENT ACUTE OTITIS MEDIA (AOM) EPISODES ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN [ Time Frame: Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (31 January 2012). ]
    The PYAR (Person-Year Rate) as regards subjects with AOM episode was tabulated. PYAR was calculated as follows n (= number of subjects reported with event) divided by T (= sum of follow-up period expressed in years) (per 1000). An AOM episode assessed as with level 1 of diagnostic certainty was defined as an AOM event diagnosed by a physician according to the Finnish AOM management guidelines (confirmed cases) and reported by subjects' parent(s)/guardian(s) regardless the documentation in medical records or other source document. Note that a post-hoc re-analysis of AOM endpoints with a corrected definition of follow-up taking into account individual end of follow-up time was performed; the results of re-analysis as the most prominent for AOM outcome are presented in this summary.

  78. PERSON YEAR RATE AS REGARDS SUBJECTS WITH RECURRENT ACUTE OTITIS MEDIA (AOM) EPISODES ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN [ Time Frame: Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (31 January 2012). ]
    The PYAR (Person-Year Rate) as regards subjects with AOM episode was tabulated. PYAR was calculated as follows n (= number of subjects reported with event) divided by T (= sum of follow-up period expressed in years) (per 1000). An AOM episode assessed as with level 1 of diagnostic certainty was defined as an AOM event diagnosed by a physician according to the Finnish AOM management guidelines (confirmed cases) and reported by subjects' parent(s)/guardian(s) regardless the documentation in medical records or other source document. Note that a post-hoc re-analysis of AOM endpoints with a corrected definition of follow-up taking into account individual end of follow-up time was performed; the results of re-analysis as the most prominent for AOM outcome are presented in this summary.

  79. PERSON YEAR RATE AS REGARDS SUBJECTS WITH RECURRENT ACUTE OTITIS MEDIA (AOM) EPISODES ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN [ Time Frame: Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (31 January 2012). ]
    The PYAR (Person-Year Rate) as regards subjects with AOM episode was tabulated. PYAR was calculated as follows n (= number of subjects reported with event) divided by T (= sum of follow-up period expressed in years) (per 1000). An AOM episode assessed as with level 1 of diagnostic certainty was defined as an AOM event diagnosed by a physician according to the Finnish AOM management guidelines (confirmed cases) and reported by subjects' parent(s)/guardian(s) regardless the documentation in medical records or other source document. Note that a post-hoc re-analysis of AOM endpoints with a corrected definition of follow-up taking into account individual end of follow-up time was performed; the results of re-analysis as the most prominent for AOM outcome are presented in this summary.

  80. PERSON YEAR RATE AS REGARDS SUBJECTS WITH ACUTE OTITIS MEDIA (AOM) EPISODE ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY AND ACCOMPANIED WITH DOCUMENTED ANTIMICROBIAL PRESCRIPTION. IN SUBJECTS RECEIVING 3+1 AND 2+1 INFANT SCHEDULES OF 10PN [ Time Frame: Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (31 January 2012). ]
    The PYAR (Person-Year Rate) as regards subjects with AOM episode was tabulated. PYAR was calculated as follows n (= number of subjects reported with event) divided by T (= sum of follow-up period expressed in years) (per 1000). An AOM episode assessed as with level 1 of diagnostic certainty was defined as an AOM event diagnosed by a physician according to the Finnish AOM management guidelines (confirmed cases) and reported by subjects' parent(s)/guardian(s) regardless the documentation in medical records or other source document. Note that a post-hoc re-analysis of AOM endpoints with a corrected definition of follow-up taking into account individual end of follow-up time was performed; the results of re-analysis as the most prominent for AOM outcome are presented in this summary.

  81. PERSON YEAR RATE AS REGARDS SUBJECTS WITH ACUTE OTITIS MEDIA (AOM) EPISODE ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY AND ACCOMPANIED WITH DOCUMENTED ANTIMICROBIAL PRESCRIPTION. IN SUBJECTS RECEIVING 7-11M SCHEDULE OF 10PN [ Time Frame: Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (31 January 2012). ]
    The PYAR (Person-Year Rate) as regards subjects with AOM episode was tabulated. PYAR was calculated as follows n (= number of subjects reported with event) divided by T (= sum of follow-up period expressed in years) (per 1000). An AOM episode assessed as with level 1 of diagnostic certainty was defined as an AOM event diagnosed by a physician according to the Finnish AOM management guidelines (confirmed cases) and reported by subjects' parent(s)/guardian(s) regardless the documentation in medical records or other source document. Note that a post-hoc re-analysis of AOM endpoints with a corrected definition of follow-up taking into account individual end of follow-up time was performed; the results of re-analysis as the most prominent for AOM outcome are presented in this summary.

  82. PERSON YEAR RATE AS REGARDS SUBJECTS WITH ACUTE OTITIS MEDIA (AOM) EPISODE ASSESSED AS WITH LEVEL 1 OF DIAGNOSTIC CERTAINTY AND ACCOMPANIED WITH DOCUMENTED ANTIMICROBIAL PRESCRIPTION. IN SUBJECTS RECEIVING 12-18M SCHEDULE OF 10PN [ Time Frame: Period of follow-up was anytime after the administration of first vaccine dose till the end of the blinded invasive disease (ID) Follow-up period (31 January 2012). ]
    The PYAR (Person-Year Rate) as regards subjects with AOM episode was tabulated. PYAR was calculated as follows n (= number of subjects reported with event) divided by T (= sum of follow-up period expressed in years) (per 1000). An AOM episode assessed as with level 1 of diagnostic certainty was defined as an AOM event diagnosed by a physician according to the Finnish AOM management guidelines (confirmed cases) and reported by subjects' parent(s)/guardian(s) regardless the documentation in medical records or other source document. Note that a post-hoc re-analysis of AOM endpoints with a corrected definition of follow-up taking into account individual end of follow-up time was performed; the results of re-analysis as the most prominent for AOM outcome are presented in this summary.

  83. Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 3-dose Primary Vaccination Course Till End of LT FU Period. [ Time Frame: Period of follow-up was any time after the administration of first vaccine dose till the end of the long-term Follow-up period (The Follow-up period lasted at least 77 months). ]
    The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.

  84. Culture-confirmed Invasive Disease (ID) Person Year Rate - In Children Starting Vaccination Within 7 Months of Life and Assigned to a 2-dose Primary Vaccination Course Till End of LT FU Period. [ Time Frame: Period of follow-up was any time after the administration of first vaccine dose till the end of the long-term Follow-up period (The Follow-up period lasted at least 77 months). ]
    The PYAR (Person-Year Rate) was calculated as follows n (= number of subjects reported with a culture confirmed IPD) divided by T (= sum of follow-up period expressed in years) (per 1000) as well as the corresponding 95% confidence interval (CI), calculated as a 2-sided profile log-likelihood ratio 95% CI using a classical log linear Poisson regression with strata.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Weeks to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study.
  • Male or female between, and including, 6 weeks to 18 months of age at the time of the first vaccination.
  • Written informed consent obtained from parent(s) or from the guardian(s) of the subject.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the first dose of study vaccine, or planned use of such a vaccine(s) other than the study vaccine(s) during the entire study period.
  • Previous vaccination with any registered, non-registered or investigational pneumococcal vaccine, or planned use of such a vaccine other than the study vaccine during the study period. If a child belongs to a high risk group for pneumococcal infections (such as children with an anatomic or functional asplenia, HIV infection, chronic cardiac or respiratory disease (not asthma), diabetes, cochlear implant, CSF fistula or with significant immunodeficiency) for which a licensed pneumococcal conjugate vaccine is made locally available, the subject can not be enrolled in the study and should be referred to the specific immunization program.
  • Previous vaccination against Hepatitis B virus with any registered, non-registered or investigational vaccine, or planned use of such a vaccine other than the study vaccine during the study period.
  • Previous vaccination against Hepatitis A virus with any registered, non-registered or investigational vaccine, or planned use of such a vaccine other than the study vaccine during the study period.
  • Known severe hypersensitivity to any component of the study vaccines, including neomycin.
  • Any medical condition that would contraindicate the initiation of routine immunization outside a clinical trial context.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00839254


Locations
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Finland
GSK Investigational Site
Espoo, Finland, 02100
GSK Investigational Site
Helsinki, Finland, 00100
GSK Investigational Site
Helsinki, Finland, 00930
GSK Investigational Site
Jarvenpaa, Finland, 04400
GSK Investigational Site
Kokkola, Finland, 67100
GSK Investigational Site
Kotka, Finland, 48600
GSK Investigational Site
Kuopio, Finland, 70210
GSK Investigational Site
Lahti, Finland, 15140
GSK Investigational Site
Oulu, Finland, 90220
GSK Investigational Site
Pori, Finland, 28100
GSK Investigational Site
Seinajoki, Finland, 60100
GSK Investigational Site
Tampere, Finland, 33100
GSK Investigational Site
Turku, Finland, 20520
GSK Investigational Site
Vantaa, Finland, 01300
GSK Investigational Site
Vantaa, Finland, 01600
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00839254    
Other Study ID Numbers: 112595
2008-006551-51 ( EudraCT Number )
First Posted: February 9, 2009    Key Record Dates
Results First Posted: July 27, 2020
Last Update Posted: August 31, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD is available via the Clinical Study Data Request site (click on the link provided below).
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
URL: https://clinicalstudydatarequest.com/Posting.aspx?ID=4324
Keywords provided by GlaxoSmithKline:
Streptococcus pneumoniae
acute otitis media
Pneumococcal conjugate vaccine
nasopharyngeal carriage
Haemophilus influenzae
immunogenicity
invasive disease
Additional relevant MeSH terms:
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Streptococcal Infections
Pneumonia
Otitis
Otitis Media
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Ear Diseases
Otorhinolaryngologic Diseases
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs