Trial record 1 of 1 for:
M5A07
Study of the Effect of Pneumococcal Conjugate Vaccine (PCV) on Immunogenicity of Pentacel™
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| ClinicalTrials.gov Identifier: NCT00772928 |
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Recruitment Status :
Completed
First Posted : October 15, 2008
Results First Posted : February 12, 2010
Last Update Posted : February 1, 2012
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Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
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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 |
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 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 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Vaccines
Drug Information available for:
Heptavalent pneumococcal conjugate vaccine
Pentacel
Pneumococcal Vaccines
| Arm | Intervention/treatment |
|---|---|
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Experimental: Pentacel™ concurrently with Prevnar®
Participants had Pentacel™ concurrently administered with Prevnar®
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Biological: Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®
0.5 mL, Intramuscular
Other Names:
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Experimental: Pentacel™ staggered schedule with Prevnar®
Participants had Pentacel™ given at different times from Prevnar® (using a standardized, staggered schedule).
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Biological: Pentacel™: HCPDT-IPV//PRP-T Vaccine and Prevnar®
0.5 mL, Intramuscular
Other Names:
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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 ]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 ]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:
- 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.
Information from the National Library of Medicine
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| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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. |
Additional Information:
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00772928 |
| Other Study ID Numbers: |
M5A07 |
| First Posted: | October 15, 2008 Key Record Dates |
| Results First Posted: | February 12, 2010 |
| Last Update Posted: | February 1, 2012 |
| Last Verified: | January 2012 |
Keywords provided by Sanofi:
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Pertussis Whooping cough Diphtheria |
Tetanus Haemophilus influenzae Poliovirus Types 1, 2, and 3. |
Additional relevant MeSH terms:
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Whooping Cough Tetanus Diphtheria Haemophilus Infections Bordetella Infections Gram-Negative Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections Respiratory Tract Infections |
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 |