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

Sanofi

Status and phase

Completed

Phase 3

Conditions

Haemophilus Infection

Diphtheria

Polio

Pertussis

Tetanus

Treatments

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00772928

M5A07

Details and patient eligibility

About

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®.

Full description

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®.

Enrollment

1,167 patients

Sex

All

Ages

42 to 89 days old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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.