Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A and Prophylactic Antipyretic Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01235949
First received: November 4, 2010
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

The aim of the current study is to determine whether ibuprofen, given as immediate or delayed prophylactic antipyretic treatment in a standardized manner, significantly impacts the immune response in children receiving primary vaccination with GlaxoSmithKline (GSK) Biologicals' 10-valent pneumococcal conjugate vaccine, co-administered with DTPa-combined vaccines, at 3, 4 and 5 months of age.

In addition, this study will further evaluate the impact of prophylactic administration of paracetamol following primary vaccination with immediate or delayed administration or when given in an immediate manner at the time of the booster dose.


Condition Intervention Phase
Infections, Streptococcal
Biological: GSK1024850A (SynflorixTM)
Biological: Infanrix hexa
Biological: Infanrix-IPV/Hib
Drug: Ibuprofen
Drug: Paracetamol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Impact of Immediate or Delayed Prophylactic Antipyretic Treatment on the Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline Biologicals' Pneumococcal Vaccine 1024850A and the Co-administered DTPa-combined Vaccines

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Evaluation of immune responses to components of the investigational vaccine [ Time Frame: One month after primary immunization (Month 3). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of each solicited adverse event. [ Time Frame: Within 4 days (Days 0 to 3) after each primary vaccination dose and following booster vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events. [ Time Frame: Within 31 days (Days 0 to 30) after each primary vaccination dose and following booster vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: During the entire study period (Month 0 to 10) ] [ Designated as safety issue: No ]
  • Evaluation of immune responses to components of the investigational vaccine for additional parameters. [ Time Frame: One month after primary immunization (Month 3), prior (Month 9) to and one month (Month 10) after booster immunization. ] [ Designated as safety issue: No ]
  • Evaluation of immune responses to components of the co-administered DTPa-combined vaccines. [ Time Frame: One month after primary immunization (Month 3), prior (Month 9) to and one month (Month 10) after booster immunization. ] [ Designated as safety issue: No ]

Enrollment: 850
Study Start Date: November 2010
Study Completion Date: December 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group IIBU
Immediate ibuprofen group: subjects receiving immediate ibuprofen treatment after each primary vaccine dose
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Drug: Ibuprofen
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Other Name: Nurofen for Children
Active Comparator: Group DIBU
Delayed ibuprofen group: subjects receiving delayed ibuprofen treatment after each primary vaccine dose
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Drug: Ibuprofen
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Other Name: Nurofen for Children
Active Comparator: Group NIBU
No ibuprofen group: subjects receiving no prophylactic ibuprofen treatment after each primary vaccine dose
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Experimental: Group IPARA
Immediate paracetamol group: subjects receiving immediate paracetamol treatment after each primary vaccine dose
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Drug: Paracetamol
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Other Name: Panadol Baby
Experimental: Group DPARA
Delayed paracetamol group: subjects receiving delayed paracetamol treatment after each primary vaccine dose
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Drug: Paracetamol
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Other Name: Panadol Baby
Active Comparator: Group NPARA
No paracetamol group: subjects receiving no prophylactic paracetamol treatment after each primary vaccine dose
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Experimental: Group IIBU-IIBU
1/3 of the subjects from the primary IIBU group receiving immediate ibuprofen treatment after booster vaccination
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Drug: Ibuprofen
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Other Name: Nurofen for Children
Experimental: Group IIBU-DIBU
1/3 of the subjects from the primary IIBU group receiving delayed ibuprofen treatment after booster vaccination
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Experimental: Group IIBU-NIBU
1/3 of the subjects from the primary IIBU group receiving no prophylactic ibuprofen treatment after booster vaccination
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Drug: Ibuprofen
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Other Name: Nurofen for Children
Experimental: Group DIBU-IIBU
1/3 of the subjects from the primary DIBU group receiving immediate ibuprofen treatment after booster vaccination
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Drug: Ibuprofen
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Other Name: Nurofen for Children
Experimental: Group DIBU-DIBU
1/3 of the subjects from the primary DIBU group receiving delayed ibuprofen treatment after booster vaccination
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Drug: Ibuprofen
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Other Name: Nurofen for Children
Experimental: Group DIBU-NIBU
1/3 of the subjects from the primary DIBU group receiving no prophylactic ibuprofen treatment after booster vaccination
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Experimental: Group NIBU-IIBU
1/3 of the subjects from the primary NIBU group receiving immediate ibuprofen treatment after booster vaccination
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Drug: Ibuprofen
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Other Name: Nurofen for Children
Experimental: Group NIBU-DIBU
1/3 of the subjects from the primary NIBU group receiving delayed ibuprofen treatment after booster vaccination
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Drug: Ibuprofen
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Other Name: Nurofen for Children
Active Comparator: Group NIBU-NIBU
1/3 of the subjects from the primary NIBU group receiving no prophylactic ibuprofen treatment after booster vaccination
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Experimental: Group IPARA-NPARA
subjects from the primary IPARA group receiving no paracetamol treatment after booster vaccination
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Experimental: Group DPARA-IPARA
subjects from the primary DPARA group receiving immediate paracetamol treatment after booster vaccination
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Drug: Paracetamol
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Other Name: Panadol Baby
Experimental: Group NPARA-IPARA
subjects from the primary NPARA group receiving immediate paracetamol treatment after booster vaccination
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Drug: Paracetamol
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Other Name: Panadol Baby

  Eligibility

Ages Eligible for Study:   12 Weeks to 16 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
  • A male or female between, and including, 12 and 16 weeks (84-118 days) of age at the time of the first vaccination.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Born after a gestation period of 36 to 42 weeks inclusive.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccines/products within 30 days preceding the first dose of study vaccine/product, or planned use during the study period.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (.
  • Indication, other than specified in the protocol, for prophylactic or therapeutic antipyretic treatment during the study period.
  • Treatment with antipyretics in the 24 hours before study vaccination or planned administration of antipyretics in the 24 hours after study vaccination.
  • Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
  • Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of study vaccine and ending 30 days after with the exception of locally recommended (pandemic) influenza vaccines, and those should be documented in the eCRF.
  • Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae with the exception of the vaccines where the first dose may be given within the first two weeks of life according to the national recommendations.
  • History of intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b disease.
  • History of any allergic disease or reaction likely to be exacerbated by any component of the vaccines or prophylactic antipyretic treatment, i.e. ibuprofen or paracetamol, as specified in the protocol.
  • History of any seizures or progressive neurological disease.
  • Acute disease and/or fever at the time of enrolment. The study entry should be delayed until the illness has improved.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination .
  • A family history of congenital or hereditary immunodeficiency.
  • Major congenital defects or serious chronic illness.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during entire study period.
  • Any contraindication to treatment with ibuprofen as described in the ibuprofen summary of product characteristics (SPC).
  • Any contraindication to treatment with paracetamol as described in the paracetamol SPC.
  • Body weight < 5 kg at the time of enrolment.
  • Child in care.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01235949

Locations
Romania
GSK Investigational Site
Bacau, Romania, 600316
GSK Investigational Site
Braila, Romania, 810289
GSK Investigational Site
Braila, Romania, 810346
GSK Investigational Site
Brasov, Romania, 500063
GSK Investigational Site
Brasov, Romania, 500366
GSK Investigational Site
Brasov, Romania, 500260
GSK Investigational Site
Bucharest, Romania, 051821
GSK Investigational Site
Bucharest, Romania, 077190
GSK Investigational Site
Bucuresti, Romania, 030442
GSK Investigational Site
Bucuresti, Romania, 050734
GSK Investigational Site
Calarasi, Romania, 910160
GSK Investigational Site
Cluj-Napoca, Romania, 400217
GSK Investigational Site
Constanta, Romania, 900721
GSK Investigational Site
Constanta, Romania, 900709
GSK Investigational Site
Galati, Romania, 800322
GSK Investigational Site
Galati, Romania, 800099
GSK Investigational Site
Galati, Romania, 800235
GSK Investigational Site
Galati, Romania, 800179
GSK Investigational Site
Galati, Romania, 800394
GSK Investigational Site
Iasi, Romania, 700115
GSK Investigational Site
Pantelimon, Romania, 77145
GSK Investigational Site
Sibiu, Romania, 550166
GSK Investigational Site
Timisoara, Romania
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01235949     History of Changes
Other Study ID Numbers: 112921
Study First Received: November 4, 2010
Last Updated: September 25, 2013
Health Authority: Romania: National Drug Agency

Keywords provided by GlaxoSmithKline:
Pneumococcal vaccine
Immunogenicity
Safety
Fever
Primary vaccination
Booster vaccination
Pneumococcal disease
Prophylactic antipyretic

Additional relevant MeSH terms:
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Acetaminophen
Ibuprofen
Antipyretics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2014