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

• ClinicalTrials.gov Identifier: NCT00772928
• Recruitment Status: Completed
• First Posted: October 15, 2008
• Results First Posted: February 12, 2010
• Last Update Posted: February 1, 2012
• Sponsor: Sanofi
• Information provided by (Responsible Party): Sanofi

Study Description

Brief 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®.

Condition or disease	Intervention/treatment	Phase
Diphtheria; Tetanus; Haemophilus Infection; Pertussis; Polio	Biological: Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®	Phase 3

Detailed 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®.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1167 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Study Start Date: October 2003
• Actual Primary Completion Date: May 2006
• Actual Study Completion Date: November 2006

Arms and Interventions

Arm	Intervention/treatment
Experimental: Pentacel™ concurrently with Prevnar®; Participants had Pentacel™ concurrently administered with Prevnar®	Biological: Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®; 0.5 mL, Intramuscular; Other Names: Pentacel™; Prevnar®
Experimental: Pentacel™ staggered schedule with Prevnar®; Participants had Pentacel™ given at different times from Prevnar® (using a standardized, staggered schedule).	Biological: Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®; 0.5 mL, Intramuscular; Other Names: Pentacel™; Prevnar®

Outcome Measures

Primary Outcome Measures :

1. 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®) [ Time Frame: 28 to 48 days post-3rd vaccination ]
   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.
2. 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®) [ Time Frame: 60 Days Post-dose 3 ]
   Anti-pertussis response include antibodies to Pertussis Toxoid (PT); Filamentous Haemagglutinin (FHA); Fimbriae Types 2 and 3 (FIM) and Pertactin (PRN) antigens.

Other Outcome Measures:

1. Percentage of Subjects With Solicited Local, Systemic Reactions Occurring Between 0-3 Days After Each Dose of Pentacel™ [ Time Frame: 0-3 days post- vaccination and entire study period ]
   Solicited local reactions: redness, swelling, and tenderness. Solicited systemic reactions: fever (temperature), irritability post-vaccinal, crying, lethargy, appetite decreased, vomiting, diarrhea, and rash.

Eligibility Criteria

• Ages Eligible for Study: 42 Days to 89 Days (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Alabama

Montgomery, Alabama, United States, 36106

United States, Arkansas

Fayetteville, Arkansas, United States, 72703

Jonesboro, Arkansas, United States, 72401

Little Rock, Arkansas, United States, 72205

United States, California

Fountain Valley, California, United States, 92708

Oakland, California, United States, 94612

Rolling Hills Estate, California, United States, 90274

United States, Connecticut

Norwich, Connecticut, United States, 06360

United States, Kentucky

Bardstown, Kentucky, United States, 40004

Louisville, Kentucky, United States, 40202

United States, Massachusetts

Boston, Massachusetts, United States, 02115

United States, Missouri

Kansas City, Missouri, United States, 64112

United States, New York

Brooklyn, New York, United States, 11201

United States, Pennsylvania

Norristown, Pennsylvania, United States, 19401

Pittsburgh, Pennsylvania, United States, 15241

United States, Texas

Austin, Texas, United States, 78745

Fort Worth, Texas, United States, 76107

San Antonio, Texas, United States, 78229

San Antonio, Texas, United States, 78745

United States, Utah

Layton, Utah, United States, 84041

United States, Washington

Spokane, Washington, United States, 99220

Vancouver, Washington, United States, 98864

United States, Wisconsin

Lacrosse, Wisconsin, United States, 54601

Sponsors and Collaborators

Sanofi

Investigators

• Study Director: Medical Monitor; Sanofi Pasteur Inc.

More Information

Additional Information:

Related Info 

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT00772928
• Other Study ID Numbers: M5A07
• First Posted: October 15, 2008
• Results First Posted: February 12, 2010
• Last Update Posted: February 1, 2012
• Last Verified: January 2012

Keywords provided by Sanofi:

Pertussis; Whooping cough; Diphtheria; Tetanus; Haemophilus influenzae; Poliovirus Types 1, 2, and 3.

Additional relevant MeSH terms:

Whooping Cough; Tetanus; Diphtheria; Haemophilus Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Respiratory Tract Infections; Infection; Respiratory Tract Diseases; Clostridium Infections; Gram-Positive Bacterial Infections; Corynebacterium Infections; Actinomycetales Infections; Pasteurellaceae Infections; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine; Immunologic Factors; Physiological Effects of Drugs