At a glance
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A Phase 3b, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
In Brief
A Phase 3 clinical trial evaluating MenACWY-CRM197, DTaP (Diptheria, Tetanus, Pertussis) Vaccine, and 6 other interventions for Meningitis and Meningococcal Infection. Completed, enrolled 7,744 participants across 153 sites in 6 countries.
Detailed Summary
The primary objective of this phase 3b study is to evaluate the safety and tolerability of Novartis MenACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants
Study Details
Timeline
Interventions
Four 0.5mL vaccinations of MenACWY-CRM197 conjugate vaccine was administered by intramuscular injection at 2, 4, 6 and 12 months of age.
Four vaccinations of DTaP (Diptheria, Tetanus, Pertussis) was administered at 2, 4, 6, and 15 months of age.
Four vaccinations of Hib (Haemophilus influenza b) vaccine was administered at 2, 4, 6 and 15 months of age.
Three vaccinations of IPV (Inactivated Polio Vaccine) was administered at 2, 4, and 6 months of age.
Four vaccinations of Pneumococcal conjugate vaccine was administered at 2, 4, 6 and 12 months of age.
One vaccination of MMR (Measles, Mumps, and Rubella) was administered at 12 months of age.
One vaccination of Varicella vaccine was administered at 12 months of age.
One vaccination of Hepatitis A Virus vaccine was administered at 12 months of age.