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A Study of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Infants and Toddlers

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ClinicalTrials.gov Identifier: NCT01049035
Recruitment Status : Completed
First Posted : January 14, 2010
Results First Posted : June 9, 2020
Last Update Posted : March 28, 2022
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

The purpose of this study was to evaluate the optimal vaccination schedule for a Quadrivalent Meningococcal Polysaccharide (A, C, Y and W-135) Tetanus Protein Conjugate Vaccine (MenACYW Conjugate vaccine) in order to provide an effective protein conjugate quadrivalent meningococcal vaccine in the population with the highest incidence of disease.

Objectives:

  • To describe the safety profile of MenACYW Conjugate vaccine administered at 5 different schedules and concomitantly with routine pediatric vaccinations.
  • To describe the immunogenicity profile of MenACYW Conjugate vaccine administered at 5 different schedules and concomitantly with routine pediatric vaccinations.
  • To describe the immunogenicity profiles of selected licensed pediatric vaccines (Pentacel, Prevnar, M-M-RII, and Varivax) when administered either concomitantly with or without MenACYW Conjugate vaccine.

Condition or disease Intervention/treatment Phase
Meningitis Meningococcal Infection Biological: Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein Conjugate Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined) Biological: M-M-RII-Measles, Mumps, and Rubella Virus Vaccine Live Biological: Varicella Virus Vaccine Live Biological: Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) Biological: Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) Biological: Rotavirus Vaccine Biological: Hepatitis B Vaccine Phase 2

Detailed Description:
Participants received study vaccinations beginning at age 2, 6, 12, or 15 months, depending on the assigned schedule in their randomized groups. All participants underwent safety and immunogenicity assessments according to the schedule for their assigned group.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 580 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine Administered in Infants and Toddlers
Actual Study Start Date : December 16, 2009
Actual Primary Completion Date : February 13, 2012
Actual Study Completion Date : February 13, 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1: MenACYW Conjugate Vaccine: 2, 4, 6, and 12 Months
Participants aged 2 months (at the time of enrollment) received Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein (MenACYW) Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 12 along with Prevnar 7 or Prevnar 13 vaccine at the age of Months 2, 4, 6, and 12, Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, and M-M-RII and VARIVAX vaccines at the age of 12 months.
Biological: Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein Conjugate
0.5 milliliter (mL), Intramuscular (IM) injection
Other Name: TetraMen-T

Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined)
0.5 mL, IM injection
Other Name: Pentacel

Biological: M-M-RII-Measles, Mumps, and Rubella Virus Vaccine Live
0.5 mL, Subcutaneous (SC) injection

Biological: Varicella Virus Vaccine Live
0.5 mL, SC injection
Other Name: Varivax

Biological: Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
0.5 mL, IM injection
Other Name: Prevnar

Biological: Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
0.5 mL, IM injection
Other Name: Prevnar 13

Biological: Rotavirus Vaccine
oral
Other Name: RotaTeq/ROTARIX

Biological: Hepatitis B Vaccine
0.5 mL, IM injection
Other Name: Engerix-B/Recombivax-HB

Experimental: Group 2: MenACYW Conjugate Vaccine: 2, 4, 6, and 15 Months
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4, 6, and a booster vaccination at the age of Month 15 along with Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.
Biological: Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein Conjugate
0.5 milliliter (mL), Intramuscular (IM) injection
Other Name: TetraMen-T

Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined)
0.5 mL, IM injection
Other Name: Pentacel

Biological: M-M-RII-Measles, Mumps, and Rubella Virus Vaccine Live
0.5 mL, Subcutaneous (SC) injection

Biological: Varicella Virus Vaccine Live
0.5 mL, SC injection
Other Name: Varivax

Biological: Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
0.5 mL, IM injection
Other Name: Prevnar

Biological: Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
0.5 mL, IM injection
Other Name: Prevnar 13

Biological: Rotavirus Vaccine
oral
Other Name: RotaTeq/ROTARIX

Biological: Hepatitis B Vaccine
0.5 mL, IM injection
Other Name: Engerix-B/Recombivax-HB

Experimental: Group 3: MenACYW Conjugate Vaccine: 2, 4, and 12 Months
Participants aged 2 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Months 2, 4 and a booster vaccination at the age of Month 12 along with Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, M-M-RII and VARIVAX vaccines at the age of Month 12, and Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12.
Biological: Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein Conjugate
0.5 milliliter (mL), Intramuscular (IM) injection
Other Name: TetraMen-T

Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined)
0.5 mL, IM injection
Other Name: Pentacel

Biological: M-M-RII-Measles, Mumps, and Rubella Virus Vaccine Live
0.5 mL, Subcutaneous (SC) injection

Biological: Varicella Virus Vaccine Live
0.5 mL, SC injection
Other Name: Varivax

Biological: Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
0.5 mL, IM injection
Other Name: Prevnar

Biological: Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
0.5 mL, IM injection
Other Name: Prevnar 13

Biological: Rotavirus Vaccine
oral
Other Name: RotaTeq/ROTARIX

Biological: Hepatitis B Vaccine
0.5 mL, IM injection
Other Name: Engerix-B/Recombivax-HB

Experimental: Group 4: MenACYW Conjugate Vaccine: 6 and 12 Months
Participants aged 6 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of Month 6 along with Pentacel, Prevnar 7 or 13, Hepatitis-B and Rotavirus vaccines, and a booster vaccination of MenACYW at the age of Month 12 along with M-M-RII and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2 and 4, and Hepatitis-B vaccine at the age of Month 2.
Biological: Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein Conjugate
0.5 milliliter (mL), Intramuscular (IM) injection
Other Name: TetraMen-T

Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined)
0.5 mL, IM injection
Other Name: Pentacel

Biological: M-M-RII-Measles, Mumps, and Rubella Virus Vaccine Live
0.5 mL, Subcutaneous (SC) injection

Biological: Varicella Virus Vaccine Live
0.5 mL, SC injection
Other Name: Varivax

Biological: Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
0.5 mL, IM injection
Other Name: Prevnar

Biological: Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
0.5 mL, IM injection
Other Name: Prevnar 13

Biological: Rotavirus Vaccine
oral
Other Name: RotaTeq/ROTARIX

Biological: Hepatitis B Vaccine
0.5 mL, IM injection
Other Name: Engerix-B/Recombivax-HB

Experimental: Group 5: MenACYW Conjugate Vaccine: Month 12
Participants aged 12 months (at the time of enrollment) received MenACYW Conjugate vaccine at the age of 12 months along with Prevnar 7 or 13, M-M-RII, and VARIVAX vaccines. Before enrollment, participants were vaccinated with Pentacel, Prevnar, and Rotavirus vaccines at the age of Months 2, 4, and 6, and Hepatitis-B vaccine at the age of Months 2 and 6.
Biological: Quadrivalent Meningococcal Polysaccharide (A, C, Y, and W-135) Tetanus Protein Conjugate
0.5 milliliter (mL), Intramuscular (IM) injection
Other Name: TetraMen-T

Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined)
0.5 mL, IM injection
Other Name: Pentacel

Biological: M-M-RII-Measles, Mumps, and Rubella Virus Vaccine Live
0.5 mL, Subcutaneous (SC) injection

Biological: Varicella Virus Vaccine Live
0.5 mL, SC injection
Other Name: Varivax

Biological: Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
0.5 mL, IM injection
Other Name: Prevnar

Biological: Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
0.5 mL, IM injection
Other Name: Prevnar 13

Biological: Rotavirus Vaccine
oral
Other Name: RotaTeq/ROTARIX

Biological: Hepatitis B Vaccine
0.5 mL, IM injection
Other Name: Engerix-B/Recombivax-HB

Group 6: Control: 2, 4, 6, and 12 Months
Participants aged 2 months (at the time of enrollment) received Pentacel and Rotavirus vaccines at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12 and M-M-RII and VARIVAX vaccines at the age of 12 months.
Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined)
0.5 mL, IM injection
Other Name: Pentacel

Biological: M-M-RII-Measles, Mumps, and Rubella Virus Vaccine Live
0.5 mL, Subcutaneous (SC) injection

Biological: Varicella Virus Vaccine Live
0.5 mL, SC injection
Other Name: Varivax

Biological: Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
0.5 mL, IM injection
Other Name: Prevnar

Biological: Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
0.5 mL, IM injection
Other Name: Prevnar 13

Biological: Rotavirus Vaccine
oral
Other Name: RotaTeq/ROTARIX

Biological: Hepatitis B Vaccine
0.5 mL, IM injection
Other Name: Engerix-B/Recombivax-HB

Group 7: Control: 2, 4, 6, 12, and 15 Months
Participants aged 2 months (at the time of enrollment) received Rotavirus vaccine at the age of Months 2, 4, and 6, Hepatitis-B vaccine at the age of Months 2 and 6, Prevnar 7 or 13 vaccine at the age of Months 2, 4, 6, and 12, and M-M-RII and VARIVAX vaccines at the age of 12 months, and Pentacel vaccine at the age of Months 2, 4, 6, and 15.
Biological: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus B Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined)
0.5 mL, IM injection
Other Name: Pentacel

Biological: M-M-RII-Measles, Mumps, and Rubella Virus Vaccine Live
0.5 mL, Subcutaneous (SC) injection

Biological: Varicella Virus Vaccine Live
0.5 mL, SC injection
Other Name: Varivax

Biological: Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
0.5 mL, IM injection
Other Name: Prevnar

Biological: Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
0.5 mL, IM injection
Other Name: Prevnar 13

Biological: Rotavirus Vaccine
oral
Other Name: RotaTeq/ROTARIX

Biological: Hepatitis B Vaccine
0.5 mL, IM injection
Other Name: Engerix-B/Recombivax-HB




Primary Outcome Measures :
  1. Percentage of Participants With an Serum Bactericidal Assay (SBA) Using Human Complement (SBA-HC) Titer Greater or Than Equal to (≥) 1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-protocol Population (PPP) [ Time Frame: Groups 1, 2, 4, 6, and 7: at the age of 7 months; Group 3: at the age of 5 months ]
    Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. The PPP consisted of all participants included in the trial who received at least one dose of study or control vaccine, excluding those who did not meet all protocol-specified inclusion/exclusion criteria, did not receive the correct number of doses of the investigational vaccine, received a vaccine other than the one that he/she was randomized to receive, did not provide a post-dose serology sample in the proper time window, received a protocol-restricted therapy, medication or vaccine, was on systemic antibiotics within 3 days prior to study blood draw, had no serology sample or did not produce at least one valid test result, did not receive vaccine in the proper time window. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.

  2. Percentage of Participants With an Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population [ Time Frame: Groups 1, 3, 4, and 6: at the age of 13 months; Groups 2 and 7: at the age of 16 months ]
    Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. PPP consisted of all participants included in the trial who received at least one dose of study or control vaccine, excluding those who did not meet all protocol-specified inclusion/exclusion criteria, did not received the correct number of doses of the investigational vaccine, received a vaccine other than the one that he/she was randomized to receive, did not provided a post-dose serology sample in the proper time window, received a protocol-restricted therapy, medication or vaccine, was on systemic antibiotics within 3 days prior to study blood draw, had no serology sample or did not produce at least one valid test result, did not receive vaccine in the proper time window. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.

  3. Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titer ≥1:8 and ≥1:4: Group 5 - Per-Protocol Population [ Time Frame: At the age of 13 months ]
    Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. PPP consisted of all participants included in the trial who received at least one dose of study or control vaccine, excluding those who did not meet all protocol-specified inclusion/exclusion criteria, did not received the correct number of doses of the investigational vaccine, received a vaccine other than the one that he/she was randomized to receive, did not provided a post-dose serology sample in the proper time window, received a protocol-restricted therapy, medication or vaccine, was on systemic antibiotics within 3 days prior to study blood draw, had no serology sample or did not produce at least one valid test result, did not receive vaccine in the proper time window.

  4. Percentage of Participants With SBA-HC Pre-booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population [ Time Frame: Groups 1, 3, and 4: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months); Group 2: 30 days post-vaccination at the age of 15 months (i.e. at the age of 16 months) ]
    Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Pre-booster titer was defined as titer values reported before the age of 12 months. Percentage of participants whose pre-booster titer was ≥1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30-days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.

  5. Percentage of Participants With SBA-HC Pre-vaccination Titer ≥1:8 Who Then Achieved ≥4-fold Rise in SBA-HC Titer After Vaccination: Group 5 - Per-Protocol Population [ Time Frame: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months) ]
    Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Pre-vaccination titer was defined as titer values reported before the age of 12 months. Percentage of participants whose pre-vaccination titer was ≥1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30 days post-vaccination) were reported.

  6. Percentage of Participants With SBA-HC Pre-booster Titer Less Than (<) 1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC After Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population [ Time Frame: Groups 1, 3, and 4: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months); Group 2: 30 days post-vaccination at the age of 15 months (i.e. at the age of 16 months) ]
    Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Pre-booster titer was defined as titer values reported before the age of 12 months. Percentage of participants whose pre-booster titer was <1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30-days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.

  7. Percentage of Participants With SBA-HC Pre-Vaccination Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-HC Titer After Vaccination: Group 5 - Per-Protocol Population [ Time Frame: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months) ]
    Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Percentage of participants with pre-vaccination titer <1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30-days post vaccination) were reported.

  8. Serum Bactericidal Assay Using Human Complement Geometric Mean Titers (GMTs): Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population [ Time Frame: Groups 1, 2, 4, 6, and 7: at the age of 7 months, Group 3: at the age of 5 months ]
    Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.

  9. Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population [ Time Frame: Groups 1, 3, 4, and 6: at the age of 13 months; Groups 2 and 7: at the age of 16 months ]
    Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.

  10. Serum Bactericidal Assay Using Human Complement Geometric Mean Titers: Group 5 - Per-Protocol Population [ Time Frame: At the age of 13 months ]
    Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC.

  11. Percentage of Participants With ≥4-fold Rise in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population [ Time Frame: Groups 1, 3, and 4: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months), Group 2: 30 days post-vaccination at the age of 15 months (i.e. at the age of 16 months) ]
    Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Percentage of participants with ≥4-fold rise in each meningococcal serogroups antibody titer (30 days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.

  12. Geometric Mean Fold Rise (GMFR) in SBA-HC Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population [ Time Frame: Groups 1, 3 and 4: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months), Group 2: 30 days post-vaccination at the age of 15 months (i.e. at the age of 16 months) ]
    Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-HC. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.

  13. Percentage of Participants With a Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population [ Time Frame: Groups 1, 2, 4, 6, and 7: at the age of 7 months; Group 3: at the age of 5 months ]
    Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.

  14. Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population [ Time Frame: Groups 1, 3, 4, and 6: at the age of 13 months; Groups 2 and 7: at the age of 16 months ]
    Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.

  15. Percentage of Participants With SBA-BR Titer ≥1:8 and ≥1:128: Group 5 - Per-Protocol Population [ Time Frame: At the age of 13 months ]
    Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR.

  16. Percentage of Participants With SBA-BR Pre-Booster Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population [ Time Frame: Groups 1, 3, and 4: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months); Group 2: 30 days post-vaccination at the age of 15 months (i.e. at the age of 16 months) ]
    Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Pre-booster titer was defined as titer value reported before the age of 12 months. Percentage of participants whose pre-booster titer was ≥1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30 days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.

  17. Percentage of Participants With SBA-BR Pre-Vaccination Titer ≥1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Vaccination: Group 5 - Per-Protocol Population [ Time Frame: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months) ]
    Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Percentage of participants whose pre-vaccination titer was ≥1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer at the age of Month 13 (i.e. 30-days post vaccination at Month 12) were reported.

  18. Percentage of Participants With SBA-BR Pre-Booster Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titers After Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population [ Time Frame: Groups 1, 3, and 4: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months); Group 2: 30 days post-vaccination at the age of 15 months (i.e. at the age of 16 months) ]
    Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Pre-booster titer was defined as titer value reported before the age of 12 months. Percentage of participants whose pre-booster titer was <1:8 and achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30-days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.

  19. Percentage of Participants With SBA-BR Pre-Vaccination Titer <1:8 Who Then Achieved ≥4-Fold Rise in SBA-BR Titer After Vaccination: Group 5 - Per-Protocol Population [ Time Frame: 30 days post-vaccination at the age of 12 months (i.e. at the age of 13 months) ]
    Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Pre-vaccination titer was defined as titer value reported before the age of 12 months. Percentage of participants with pre-vaccination titer <1:8 and who achieved ≥4-fold rise in each meningococcal serogroups antibody titer (30 days post-vaccination) were reported.

  20. Percentage of Participants With ≥4-fold Rise in SBA-BR Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population [ Time Frame: Groups 1, 3, and 4: 30 days post booster vaccination (i.e., at the age of 13 months); Group 2: 30 days post booster vaccination (i.e., at the age of 16 months) ]
    Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Percentage of participants with ≥4-fold rise in each meningococcal serogroups antibody titer (30-days post booster vaccination) were reported. Booster PPP was defined as the PPP which was used for reporting data of time points at and after the age of 12 months.

  21. Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population [ Time Frame: Groups 1, 2, 4, 6, and 7: at the age of 7 months; Group 3: at the age of 5 months ]
    Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.

  22. Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population [ Time Frame: Groups 1, 3, 4, and 6: at the age of 13 months; Group 2 and 7: at the age of 16 months ]
    Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.

  23. Serum Bactericidal Assay Using Baby Rabbit Complement Geometric Mean Titers in Group 5: Per-Protocol Population [ Time Frame: At the age of 13 months ]
    Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR.

  24. Geometric Mean Fold Rise in Serum Bactericidal Assay Using Baby Rabbit Complement Titer After the Booster Vaccination: Groups 1, 2, 3, and 4 - Booster Per-Protocol Population [ Time Frame: Groups 1, 3, and 4: 30 days post booster vaccination at the age of 12 months (i.e., at the age of 13 months); Group 2: 30 days post booster vaccination at the age of 15 months (i.e. at the age of 16 months) ]
    Meningococcal serogroups A, C, Y, and W-135 antibody titers were measured by SBA-BR. Percentage of participants with GMFR in each meningococcal serogroups antibody titer (30-days post booster vaccination) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.

  25. Antibody Titer/Concentration to All the Antigens Contained in Pentacel Vaccines: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population [ Time Frame: At the age of 7 months ]
    Pentacel vaccine is Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined). Antibody titer to all antigens contained in pentacel vaccines (i.e., Anti-PRP, Anti-Diptheria, Anti-pertussis [pertussis toxoid [PT], pertactin [PRN], filamentous hemagglutinin [FHA], and fimbriae [FIM]], Anti-poliovirus [anti-poliovirus Type 1, Type 2 and Type 3] and anti-tetanus) were reported. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.

  26. Antibody Titer/Concentration to All Antigens Contained in Pentacel Vaccines: Groups 2 and 7 - Booster Per-Protocol Population [ Time Frame: At the age of 16 months ]
    Pentacel vaccine is Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine Combined (DTaP-IPV/Hib combined). Antibody titer to all antigens contained in pentacel vaccines (i.e., Anti-PRP, Anti-Diptheria, Anti-pertussis [PT, PRN, FHA, and FIM], Anti-poliovirus [anti-poliovirus Type 1, Type 2, and Type 3], and Anti-tetanus) were reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.

  27. Percentage of Participants With Antibody Concentration ≥0.35 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 2, 4, 6, and 7 - Primary Series Per-Protocol Population [ Time Frame: At the age of 7 months ]
    Percentage of participants with anti-pneumococcal antibody concentrations ≥0.35 μg/mL for serotypes in Prevnar 7 or 13 vaccine i.e. 4, 6B, 9V, 14, 18C, 19F, and 23F is reported. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age.

  28. Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Groups 1, 3, 4, and 6 - Booster Series Per-Protocol Population [ Time Frame: At the age of 13 months ]
    Percentage of participants with anti-pneumococcal antibody concentrations ≥0.35 μg/mL and ≥1.0 μg/mL for serotypes in Prevnar 7 or 13 vaccine i.e. 4, 6B, 9V, 14, 18C, 19F and 23F is reported. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.

  29. Percentage of Participants With Antibody Concentration ≥0.35 μg/mL and ≥1.0 μg/mL for Serotypes in Prevnar 7 or 13 Vaccine: Group 5- Per-Protocol Population [ Time Frame: At the age of 13 months ]
    Percentage of participants with anti-pneumococcal antibody concentrations ≥0.35 μg/mL and ≥1.0 μg/mL for serotypes in Prevnar 7 or 13 vaccine i.e. 4, 6B, 9V, 14, 18C, 19F and 23F is reported.

  30. Percentage of Participants With Antibodies to All Antigens Contained in M-M-RII and VARIVAX Vaccines: Groups 1 and 6 - Booster Per-Protocol Population [ Time Frame: At the age of 13 months ]
    Antibodies responses were measured by ELISA. Antigens contained in M-M-RII: Measles, Mumps, and Rubella and in Varivax®: Varicella. Percentage of participants with anti-measles, anti-mumps, anti-rubella, and anti-varicella antibody concentration that met the respective mentioned criterion were reported: Measles: ≥255 milli-International Units per milliliter (mIU/mL); Mumps: ≥10 Antibody units per milliliter (AbU/mL); Rubella: ≥10 International Units per milliliter (IU/mL); Varicella: ≥5 glycoprotein based enzyme-linked immunosorbent assay (gpELISA) unit/mL. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months.

  31. Geometric Mean Concentrations (GMCs) of Antibody Titers to Tetanus Toxoid: Groups 1, 2, 3, 4, 6, and 7 - Primary Series Per-Protocol Population [ Time Frame: Groups 1, 2, 4, 6, and 7: at the age of 7 months; Group 3: at the age of 5 months ]
    Antibody concentrations against tetanus toxoid were measured by ELISA and expressed as GMC. Primary series PPP was defined as the PPP which was used for reporting data of time points prior to 12 months of age. Here, '0' in number analyzed field signifies none of the participants were evaluable at that specified time point because different groups had different planned data collection time points as defined in time frame and pre-specified in protocol.

  32. Geometric Mean Concentrations of Antibodies to Tetanus Toxoid: Groups 1, 2, 3, 4, 6, and 7 - Booster Per-Protocol Population [ Time Frame: Groups 1, 3, 4, and 6: at the age of 13 months, Group 2 and 7: at the age of 16 months ]
    Antibody concentrations against tetanus toxoid were measured by ELISA and expressed as GMC. Booster PPP was defined as the PPP that was used for reporting data of time points at and after the age of 12 months. Here, '0' in number analyzed field signifies none of the participants were evaluable at that specified time point because different groups had different planned data collection time points as defined in time frame and pre-specified in protocol.

  33. Geometric Mean Concentrations of Antibodies to Tetanus Toxoid: Group 5 - Per-Protocol Population [ Time Frame: At the age of 13 months ]
    Antibody concentrations against tetanus toxoid were measured by ELISA and expressed as GMC.

  34. Number of Participants With Solicited Injection Site Reactions [ Time Frame: Within 7 days post any vaccination ]
    Solicited injection site reactions: tenderness/pain, erythema, and swelling and were planned to be collected and reported for each vaccine separately and not planned to be collected for Rotavirus vaccine. Here, '0' in number analyzed field for MenACYW categories signifies no participant were evaluable because in Groups 6 and 7 MenACYW vaccine was not administered; for Group 5, '0' in number analyzed field signifies safety data collection was not planned for Pentacel and Hepatitis-B vaccines; for Groups 2 and 7, '0' in number analyzed field signifies safety data collection was not planned for M-M-RII and VARIVAX vaccines, as pre-specified.

  35. Number of Participants With Solicited Systemic Reactions [ Time Frame: Within 7 days post any vaccination ]
    An solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the electronic case report form (eCRF). Systemic AEs were all AEs that were not injection site reactions. They, therefore, include systemic manifestations as well as localized or topical manifestations that were not associated with the vaccination site. Solicited systemic reactions included Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability.

  36. Number of Participants With Unsolicited Adverse Events [ Time Frame: Within 30 days post any vaccination ]
    An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. These included both serious and non-serious events.

  37. Number of Participants With Immediate Unsolicited AE [ Time Frame: Within 30 minutes post any vaccination ]
    An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. These included both serious and non-serious events. Immediate Unsolicited AE were AEs reported within 30 minutes of vaccine administration.



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:   42 Days to 365 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Groups 1, 2, 3, 6, and 7: Aged 42 to 89 days on the day of inclusion; Group 4: Aged 6 months (180 days ± 14 days) on the day of inclusion; Group 5: Aged 12 months (365 days + 14 days) on the day of inclusion.
  • Born at full term of pregnancy (greater than or equal to [≥] 37 weeks) and with a birth weight ≥2.5 kilogram (kg).
  • Informed consent form had been signed and dated by the parent or other legally acceptable representative.
  • Participant and parent/guardian were able to attend all scheduled visits and to be complied with all trial procedures.
  • Group 4 only: Prior receipt of Pentacel and Prevnar at 2 and 4 months; 1 or 2 doses of rotavirus vaccine; and 2 or 3 previous doses of hepatitis B vaccine.

Group 5 only: Prior receipt of Pentacel and Prevnar at 2, 4, and 6 months; 2 or 3 doses of rotavirus vaccine; and 3 previous doses of hepatitis B vaccine.

Exclusion Criteria:

  • Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination.
  • Planned participation in another clinical trial during the present trial period.
  • Receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
  • Planned receipt of any vaccine in the 4 weeks following any trial vaccination, with the exception of influenza vaccine, which may be received 14 days before or after MenACYW Conjugate vaccine.
  • Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine.
  • Receipt of blood or blood-derived products in the past 30 days, which might interfere with assessment of the immune response.
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks).
  • Known personal or maternal seropositivity for human immunodeficiency virus (HIV), hepatitis B vaccine, or hepatitis C, as reported by the parent/guardian.
  • History of meningococcal infection, confirmed either clinically, serologically, or microbiologically.
  • At high risk for meningococcal infection during the trial.
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances.
  • Thrombocytopenia, as reported by the parent/guardian.
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
  • History of seizures.
  • Personal or family history of Guillain-Barré Syndrome (GBS).
  • Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion.

Temporary contraindications were resolved before vaccination:

  • Febrile illness (temperature ≥38.0 degree Celsius [≥100.4 degree Fahrenheit]) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination.
  • Group 5 only: Receipt of oral or injected antibiotic therapy within the 72 hours prior to the study blood draw. Topical antibiotics or antibiotic drops were not included in this exclusion criterion. (Note: This did not applied to the other groups at this time, as they did not have a blood draw within 30 days of the initial visit.).

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): NCT01049035


Locations
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United States, Alabama
Birmingham, Alabama, United States, 35205
Tuscaloosa, Alabama, United States, 35406
United States, Arkansas
Jonesboro, Arkansas, United States, 72401
Little Rock, Arkansas, United States, 72205
United States, California
Fountain Valley, California, United States, 92708
Huntington Beach, California, United States, 92647
United States, Georgia
Marietta, Georgia, United States, 30062
Woodstock, Georgia, United States, 30189
United States, Kentucky
Bardstown, Kentucky, United States, 40004
Crestview Hills, Kentucky, United States, 41017
Louisville, Kentucky, United States, 40207
Louisville, Kentucky, United States, 40291
United States, Louisiana
Bossier City, Louisiana, United States, 71111
United States, North Carolina
Clyde, North Carolina, United States, 28721
United States, Ohio
Cleveland, Ohio, United States, 44121
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15241
United States, South Carolina
Barnwell, South Carolina, United States, 29812
United States, Tennessee
Clarksville, Tennessee, United States, 37043
United States, Texas
Fort Worth, Texas, United States, 76107
United States, Utah
Layton, Utah, United States, 84041
Orem, Utah, United States, 84057
Springville, Utah, United States, 84663
United States, Virginia
Midlothian, Virginia, United States, 23113
United States, Washington
Spokane, Washington, United States, 99202
Spokane, Washington, United States, 99218
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01049035    
Other Study ID Numbers: MET39
UTN: U1111-1112-2593 ( Other Identifier: WHO )
First Posted: January 14, 2010    Key Record Dates
Results First Posted: June 9, 2020
Last Update Posted: March 28, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Meningitis
Meningococcal Infection
Neisseria meningitidis
Tetravalent Meningococcal Vaccine
Additional relevant MeSH terms:
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Meningococcal Infections
Meningitis
Infections
Central Nervous System Diseases
Nervous System Diseases
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs