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

Tetanus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00772928
• Other study ID #: M5A07
• Status: Completed
• Phase: Phase 3
• First received: October 13, 2008
• Last updated: January 30, 2012
• Start date: October 2003
• Est. completion date: November 2006

Study information

• Verified date: January 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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®.

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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1167
• Est. completion date: November 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 42 Days to 89 Days

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Haemophilus Infection
• Haemophilus Infections
• Pertussis
• Polio
• Tetanus

Intervention

Biological:
• Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®
0.5 mL, Intramuscular
• Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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®)	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	No
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®)	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	No

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