RotaTeq® and Meningococcus C Vaccine in Healthy Infants (V260-016)

Meningitis, Meningococcal Clinical Trial

Official title:

An Open-label, Randomised, Comparative, Multi-centre Study of the Immunogenicity and Safety of the Concomitant Use of a Live Pentavalent Rotavirus Vaccine (RotaTeq®) and a Meningococcal Group C Conjugate (MCC) Vaccine in Healthy Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00443846
• Other study ID #: V260-016
• Secondary ID: S06-ROT-3042006-
• Status: Completed
• Phase: Phase 3
• Start date: February 13, 2007
• Est. completion date: October 23, 2007

Study information

• Verified date: September 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Primary objective:

To check if RotaTeq® can be administered concomitantly with meningococcal Group C vaccine without impairing the efficacy of MCC vaccine. The hypothesis tested is that the seroprotection rate for MMC at 28 days after the second MCC vaccination with concomitant administration of RotaTeq® is non-inferior to that without non-concomitant (sequential) administration of RotaTeq®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: October 23, 2007
• Est. primary completion date: September 4, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 42 Days to 55 Days

Eligibility

Inclusion Criteria:

• Healthy infants, aged from 6 weeks through full 7 weeks,

• Consent form signed by at least one parent or by the legal representative properly informed about the study,

• Parent(s) / legal representative able to understand the protocol requirements and to fill in the Diary Card.

Exclusion Criteria:

• History of congenital abdominal disorders, congenital malformation of the gastrointestinal tract that could predispose to intussusception, or abdominal surgery,

• Congenital fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency,

• Known or suspected impairment of immunological function,

• Known hypersensitivity to any component of RotaTeq® (e.g. sucrose) or of NeisVac-C® (including tetanus toxoid),

• Prior administration of any rotavirus vaccine,

• Prior administration of any vaccine within the 28 days prior to randomisation,

• Fever (rectal temperature =38.1°C) and/or acute diarrhoea and/or vomiting at randomisation,

• History of known prior rotavirus gastroenteritis, chronic diarrhoea, or failure to thrive,

• Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,

• Clinical evidence of active gastrointestinal illness,

• Receipt of intramuscular, oral, or intravenous corticosteroid treatment within the 14 days prior to randomisation. Note: Infants on inhaled and/or topical steroids may participate in the study,

• Infants residing in a household with an immunocompromised person,

• Prior receipt of a blood transfusion or blood products, including immunoglobulins.

Related Conditions & MeSH terms

• Meningitis
• Meningitis, Meningococcal
• Rotavirus Infections

Intervention

Biological:
• RotaTeq®
Rotavirus vaccine, live, oral, pentavalent, 2 mL solution for oral administration.
• NeisVac-C®
Meningiococcal Group C Polysaccharide Conjugate Vaccine Absorbed, 0.5 mL suspension for intramuscular injection.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Seroresponse for Meningiococcal Group C Serotype	Antibody seroprotection to meningiococcal Group C serotype was measured by serum bactericidal antibody with rabbit complement (sRBA). The criterion for seroresponse was an sRBA titer >=1:8.	28 days after the second dose of MCC vaccine (approximately 20 weeks)