Study of the Effect of Pneumococcal Conjugate Vaccine (PCV) on Immunogenicity of Pentacel™
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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 |
- 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:
|
|
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:
|
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 |
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| 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 | |
| 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 May 16, 2013