Phase 3
N=1,166
Study of the Effect of Pneumococcal Conjugate Vaccine (PCV) on Immunogenicity of Pentacel™
Diphtheria · Tetanus · Haemophilus Infection · Pertussis · Polio
Bottom Line
View on ClinicalTrials.gov: NCT00772928 ↗Enrolled (actual)
1,166
Serious AEs
4.0%
Results posted
Feb 2010
Primary outcome: Primary: Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) — 90; 90; 82; 82 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar® (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Sanofi
- Primary completion
- May 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With 4-fold Rises in Levels of Pentacel™ Vaccine Antibody Titers Post-dose 3 When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) |
90; 90; 82; 82; 88; 88 | — |
| PRIMARY Geometric Mean Titers of Antibodies to Pertussis, Diphtheria, Tetanus, Polyribosylribitol Phosphate and Poliovirus Elicited by an Infant Series of Pentacel™ When Given at Different Times or Concurrently With a Pneumococcal Conjugate Vaccine (Prevnar®) |
103.58; 102.78; 82.41; 77.80; 272.47; 280.97 | — |
Summary
This study is designed to evaluate in a controlled manner the effect of Prevnar® on the immune responses of Pentacel™
Primary Objective - Stage I:
To compare the immune responses elicited by an infant series of Pentacel™ when given at different times from or concurrently with a Pneumococcal conjugate vaccine (Prevnar®).
Primary Objective - Stage II:
To compare the immune responses elicited by a 4th dose of Pentacel™ when given at different times from or concurrently with Prevnar®.
Eligibility Criteria
Inclusion Criteria
- Healthy infants 2 months (≥ 42 days and ≤ 89 days) of age.
- Infants with at least 36 weeks of gestation at delivery.
- Must have received 1 dose of Hepatitis B vaccine (with that dose at least 15 days before the administration of study vaccines).
- Able to attend the scheduled visits and to comply with the study procedures.
- Parent or legal guardian willing to take rectal temperatures during the infant series.
- Parent or legal guardian has access to a telephone.
- Signed informed consent from parent or legal guardian obtained before the 1st study intervention.
- Able to obtain at least 1.5 mL of blood sample prior to Dose 1.
Exclusion Criteria
- Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion).
- Known or suspected hypersensitivity to any component of the study vaccine to be administered.
- Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
- Known Human Immunodeficiency Virus (HIV)-positive mother or child.
- Personal or immediate family history of congenital immune deficiency.
- Developmental delay or neurologic disorder.
- Chronic medical, congenital, or developmental disease.
- Participation in any other clinical trial.
- Any condition which, in the opinion of the investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.
- Prior history of having received any Acellular Pertussis- (DTaP) or Whole Cell Pertussis- (DTwP) based combination vaccines, Haemophilus influenzae Type b (Hib)-conjugate, Poliovirus, or Pneumococcal conjugate vaccines.
Data sourced from ClinicalTrials.gov (NCT00772928). 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.