Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED)
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00130832
First received: August 12, 2005
Last updated: January 27, 2011
Last verified: January 2011
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Purpose
The study is being conducted to demonstrate that vaccine to prevent gastroenteritis due to rotavirus may be administered concomitantly with oral polio vaccine (OPV) without impairing the safety or immunogenicity of either vaccine.
| Condition | Intervention | Phase |
|---|---|---|
|
Rotavirus Infections Gastroenteritis |
Biological: Rotavirus Vaccine, Live, Oral, Pentavalent Biological: Comparator: Oral Poliovirus Vaccine (OPV) Biological: Comparator: Oral Poliovirus Vaccine (OPV) (staggered) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Safety and Immunogenicity of Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants |
Resource links provided by NLM:
Drug Information available for:
Rotavirus vaccine, live, oral, pentavalent
Rotarix
Poliovirus Vaccines
U.S. FDA Resources
Further study details as provided by Merck:
Primary Outcome Measures:
- Geometric Mean Titer(s) of Poliovirus Types 1, 2, and 3, Measured Approximately 42 Days Postdose 3 [ Time Frame: Approximately 42 days Postdose 3 ] [ Designated as safety issue: No ]GMT of poliovirus type 1, 2, and 3, measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered.
- GMT of Serum Anti-rotavirus Immunoglobulin A (IgA) [ Time Frame: Approximately 42 days Postdose 3 ] [ Designated as safety issue: No ]GMT of serum anti-rotavirus IgA measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered
- Immunogenicity of RotaTeq™ as Measured by Serum Neutralizing Antibody [SNA] Responses to Rotavirus Serotypes G1, G2, G3, G4, and P1A When Administered With OPV Concomitantly or Staggered [ Time Frame: Approximately 42 days Postdose 3 ] [ Designated as safety issue: No ]Rotavirus SNA response to serotypes G1, G2, G3, G4, and P1A measured at postdose 3 in subjects receiving RotaTeq™ and OPV concomitantly compared to staggered.
| Enrollment: | 735 |
| Study Start Date: | October 2005 |
| Study Completion Date: | July 2006 |
| Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
RotaTeq and OPV concomitantly
|
Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
Three doses of rotavirus vaccine, live, oral, pentavalent. Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2.
Biological: Comparator: Oral Poliovirus Vaccine (OPV)
Three doses OPV. Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2.
|
|
Experimental: 2
RotaTeq and OPV on staggered schedule
|
Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
Three doses of rotavirus vaccine, live, oral, pentavalent. Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2.
Biological: Comparator: Oral Poliovirus Vaccine (OPV) (staggered)
Three doses OPV. Dose 1 was given 14 to 28 days post Dose 1 of RotaTeq, Dose 2 was given 14 to 28 days post Dose 2 of RotaTeq, and Dose 3 was given 14 to 28 days post Dose 3 of RotaTeq.
|
Eligibility| Ages Eligible for Study: | 6 Weeks to 12 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Infants in good health
Exclusion Criteria:
- Previous administration of any oral poliovirus vaccine (OPV) and rotavirus vaccine
- Receipt of inactivated poliovirus vaccine (IPV) prior to the first dose of either study vaccine, or at any time during the course of the study
- Any condition resulting in depressed immunity
- Any allergy to any vaccine component as stated in the package circulars
- Allergies to polymyxin B, neomycin or any other antibiotics
- Receipt of intramuscular, oral, or intravenous corticosteroid treatment
- History of congenital abdominal disorders, intussusception, or abdominal surgery; clinical evidence of active gastrointestinal illness
- History of known prior rotavirus gastroenteritis, chronic diarrhea, or failure to thrive
- Prior receipt of a blood transfusion or blood products, including immunoglobulin
- Fever, with a rectal temperature of ≥38.1°C (≥ 100.5°F) at the time of immunization
- Infants residing in a household with an immunocompromised person
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Vice President of Late Stage Development, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00130832 History of Changes |
| Other Study ID Numbers: | V260-014, 2005_030 |
| Study First Received: | August 12, 2005 |
| Results First Received: | August 7, 2009 |
| Last Updated: | January 27, 2011 |
| Health Authority: | Brazil: Ministry of Health |
Additional relevant MeSH terms:
|
Gastroenteritis Rotavirus Infections Gastrointestinal Diseases Digestive System Diseases |
Reoviridae Infections RNA Virus Infections Virus Diseases |
ClinicalTrials.gov processed this record on May 23, 2013