Phase 3
N=606
Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Infants
Vaccines, Pneumococcal
Bottom Line
View on ClinicalTrials.gov: NCT00366899 ↗Enrolled (actual)
606
Serious AEs
2.5%
Results posted
Feb 2013
Primary outcome: Primary: Percentage of Participants Reporting Pre-Specified Local Reactions — 32.1; 30.0; 30.4; 36.7 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 13-valent pneumococcal conjugate vaccine (Biological); 7 valent pneumococcal conjugate vaccine (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Reporting Pre-Specified Local Reactions |
32.1; 30.0; 30.4; 36.7; 47.2; 44.1 | — |
| PRIMARY Percentage of Participants Reporting Pre-Specified Systemic Events |
41.7; 38.6; 55.5; 60.6; 63.7; 52.3 | — |
| PRIMARY Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose |
99.6; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| PRIMARY Geometric Mean Antibody Concentration (GMC) of Pertussis in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose |
102.87; 105.17; 463.23; 456.55; 50.01; 48.44 | — |
| PRIMARY Geometric Mean Antibody Concentration (GMC) for Hepatitis B in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After Toddler Dose |
260.46; 272.67; 1655.30; 2284.95 | — |
| PRIMARY Geometric Mean Antibody Concentration (GMC) of Haemophilus Influenzae Type b (Hib) in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose |
0.99; 1.00; 9.09; 8.85 | — |
| PRIMARY Geometric Mean Antibody Concentration (GMC) of Diptheria and Tetanus in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose |
0.52; 0.67; 2.77; 3.71; 0.53; 0.63 | — |
| PRIMARY Geometric Mean Antibody Concentration (GMC) of Polio Types 1, 2, and 3 in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose |
180.72; 207.17; 924.52; 1348.04; 123.74; 130.39 | — |
| PRIMARY Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose |
96.6; 66.9; 58.4; 76.3; 94.7; 70.5 | — |
| PRIMARY Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose |
2.38; 0.53; 0.41; 0.61; 1.68; 0.48 | — |
| SECONDARY Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose |
4.77; 7.08; 10.00; 10.39; 3.02; 4.10 | — |
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 vaccinations in Italy.
Eligibility Criteria
Inclusion criteria
- Aged 3 months (75 to 105 days) at 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.
- Born at greater than 32 weeks gestational age and greater than 2000 grams. Regardless of gestational age and birth weight, all subjects must have met inclusion criterion number 3.
- 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 hepatitis B vaccines.
- A previous anaphylactic reaction to any vaccine or vaccine-related component.
- Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B, or pneumococcal 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 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. 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® [MedImmune]).
- 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 (NCT00366899). 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.