Phase 3
N=286
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
Vaccines, Pneumococcal
Bottom Line
View on ClinicalTrials.gov: NCT00384059 ↗Enrolled (actual)
286
Serious AEs
1.5%
Results posted
Aug 2012
Primary outcome: Primary: Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series. — 99.2; 99.2; 96.5; 98.0 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 13-valent Pneumococcal Conjugate Vaccine (Biological); 7vPnC (Biological); Pediacel (Biological); NeisVac-C (Biological); Menitorix (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer ≥1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series. |
99.2; 99.2; 96.5; 98.0; 85.1; 89.2 | — |
| PRIMARY Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series |
306.20; 345.42 | — |
| PRIMARY Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series |
3.40; 4.44 | — |
| PRIMARY Geometric Mean Antibody Concentration of Pertusis Filamentous Haemagglutinin (FHA), Pertussis Toxoid (PT), Pertactin (PRN), and Fimbrial Agglutinogens (FIM) as Measured by ELISA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series |
54.74; 55.99; 66.26; 67.05; 61.33; 61.07 | — |
| PRIMARY Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration ≥0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose |
95.3; 24.7; 99.0; 40.2; 74.4; 98.0 | — |
| PRIMARY Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. |
1.37; 0.21; 3.52; 0.26; 0.77; 7.67 | — |
| SECONDARY Percentage of Participants Achieving an SBA Titer ≥1:8 for Meningococcal C in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose. |
44.1; 49.5; 91.7; 91.8 | — |
| SECONDARY Percentage of Participants Achieving a Predefined Antibody Level for Haemophilus Influenzae Type b in the 13vPnC Group Relative to the 7vPnC Group After the Toddler Dose. |
100.0; 100.0; 99.0; 100.0 | — |
| SECONDARY Geometric Mean Antibody Concentration for Haemophilus Influenzae Type b PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose. |
22.22; 19.75 | — |
| SECONDARY Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose |
656.11; 771.67 | — |
Summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccines in the United Kingdom.
Eligibility Criteria
Inclusion Criteria
- Aged 2 months (42 to 98 days) at the time of enrollment.
- Available for entire study period and whose parent(s)/legal guardian(s) could be reached by telephone.
- Healthy infant, as determined by medical history, physical examination, and judgment of the investigator.
- Parent(s)/legal guardian(s) had to be able to complete all relevant study procedures during study participation.
Exclusion Criteria
- Previous vaccination with licensed or investigational pneumococcal vaccine.
- Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or meningococcal vaccines.
- A previous anaphylactic reaction to any vaccine or vaccine-related component.
- Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, pneumococcal conjugate, or meningococcal conjugate vaccines.
- Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- Known or suspected immune deficiency or suppression.
- History of culture-proven invasive disease caused by S pneumoniae, Neisseria meningitidis, or Hib.
- Major known congenital malformation or serious chronic disorder.
- Significant neurological disorder or history of seizure, including febrile seizure, or significant stable or evolving disorders, such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. This did not include resolving syndromes due to birth trauma such as Erb palsy.
- Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®).
- Participation in another investigational trial. Participation in purely observational studies was acceptable.
- Infant who was a direct descendant (eg, child or grandchild) of the study site personnel.
Data sourced from ClinicalTrials.gov (NCT00384059). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.