NCT01839175 - Concomitant Administration of a New Hexavalent Vaccine With a Meningococcal Serogroup C Conjugate Vaccine in Healthy Infants During Primary Series Immunisation Followed by Booster Vaccination | Biotech Hunter

Enrollment

350

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

July 31, 2014

Study Completion Date

February 28, 2015

Conditions

Neisseria MeningitidisBacterial InfectionsVirus Diseases

Interventions

BIOLOGICAL

Hexavalent vaccine

0.5 mL intramuscular injection at 2, 3 and 4 months of age (primary series) 0.5 mL intramuscular injection at 12 or 13 months of age (booster)

BIOLOGICAL

NeisVac-C

0.5 mL intramuscular injection at 2 and 4 months of age

BIOLOGICAL

Prevenar 13

0.5 mL intramuscular injection at 2 and 4 months of age (primary series) 0.5 mL intramuscular injection at 13 months of age (booster)

BIOLOGICAL

RotaTeq

2 mL oral administration at 2, 3 and 4 months

BIOLOGICAL

Nimenrix

0.5 mL intramuscular injection at 12 months

BIOLOGICAL

M-M-RVAXPRO

0.5 mL intramuscular or subcutaneous injection at 13 months of age

Trial Locations (11)

Sanofi Pasteur MSD Investigational Site 003, Espoo

Sanofi Pasteur MSD Investigational Site 001, Helsinki

Sanofi Pasteur MSD Investigational Site 002, Helsinki

Sanofi Pasteur MSD Investigational Site 011, Järvenpää

Sanofi Pasteur MSD Investigational Site 010, Kokkola

Sanofi Pasteur MSD Investigational Site 004, Oulu

Sanofi Pasteur MSD Investigational Site 005, Pori

Sanofi Pasteur MSD Investigational Site 009, Seinäjoki

Sanofi Pasteur MSD Investigational Site 006, Tampere

Sanofi Pasteur MSD Investigational Site 007, Turku

Sanofi Pasteur MSD Investigational Site 008, Vantaa

All Listed Sponsors

lead

Sanofi Pasteur, a Sanofi Company

INDUSTRY