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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00772928
First received: October 13, 2008
Last updated: January 30, 2012
Last verified: January 2012
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    Anti-pertussis response include antibodies to Pertussis Toxoid (PT); Filamentous Haemagglutinin (FHA); Fimbriae Types 2 and 3 (FIM) and Pertactin (PRN) antigens.


Enrollment: 1167
Study Start Date: October 2003
Study Completion Date: November 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

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®.

  Eligibility

Ages Eligible for Study:   42 Days to 89 Days
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772928

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:
No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00772928     History of Changes
Other Study ID Numbers: M5A07
Study First Received: October 13, 2008
Results First Received: September 23, 2009
Last Updated: January 30, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Pertussis
Whooping cough
Diphtheria
Tetanus
Haemophilus influenzae
Poliovirus Types 1, 2, and 3.

Additional relevant MeSH terms:
Diphtheria
Haemophilus Infections
Whooping Cough
Poliomyelitis
Tetanus
Tetany
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pasteurellaceae Infections
Gram-Negative Bacterial Infections
Bordetella Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Clostridium Infections
Neuromuscular Manifestations
Neurologic Manifestations

ClinicalTrials.gov processed this record on July 22, 2014