Study of the Effect of Pneumococcal Conjugate Vaccine (PCV) on Immunogenicity of Pentacel™

Study Overview
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Brief Summary
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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®.

Detailed Description
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This is a 2-staged study. Stage I of this study is designed to compare the immune responses elicited by an infant series (3 doses) of Pentacel™ when given at different times from or concurrently with Prevnar®. Stage II is designed to describe the immune responses elicited by a 4th dose of Pentacel™ (all antigens) when given at different times from or concurrently with Prevnar®.

Official Title
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Immunogenicity Assessment of Pentacel™ (Hybrid CP20/20/5/3DT-mIPV//PRP-T) When Given at Different Times From or Concurrently With a Pneumococcal Conjugate Vaccine

Conditions
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Diphtheria, Tetanus, Haemophilus Infection, Pertussis, Polio

Intervention / Treatment
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* Biological: Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®
* Biological: Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 42 Days
Maximum Age: 89 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pentacel™ concurrently with Prevnar®<br>Participants had Pentacel™ concurrently administered with Prevnar® | Biological: Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®<br>* 0.5 mL, Intramuscular<br>* Other names: Prevnar®;|
| Experimental: Pentacel™ staggered schedule with Prevnar®<br>Participants had Pentacel™ given at different times from Prevnar® (using a standardized, staggered schedule). | Biological: Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®<br>* 0.5 mL, Intramuscular<br>* Other names: Prevnar®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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®) | Seroconversion was defined as the percentage of subjects with ≥ 4-fold post-dose 3 for anti-pertussis and ≥ 0.15 μg/mL or ≥ 1.0 μg/mL for anti-Polyribosylribitol Phosphate (PRP) responses. | 28 to 48 days post-3rd vaccination | 
| 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®) | Anti-pertussis response include antibodies to Pertussis Toxoid (PT); Filamentous Haemagglutinin (FHA); Fimbriae Types 2 and 3 (FIM) and Pertactin (PRN) antigens. | 60 Days Post-dose 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pertussis, Whooping cough, Diphtheria, Tetanus, Haemophilus influenzae, Poliovirus Types 1, 2, and 3.