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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
7,744
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.
Percentages of Subjects With At Least One Severe Systemic Reaction After Any Vaccination
To compare the percentages of subjects who reported at least one severe systemic reaction after any vaccination of MenACWY-CRM197 (detailed) plus routine vaccines (detailed) group to that observed in the routine vaccines alone (detailed) group administered at 2, 4, 6, and 12 months of age. Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs.
Time frame: 15 minutes to Day 7 after any vaccination administered at 2, 4, 6 and 12 months of age
Percentages of Subjects With At Least One Serious Adverse Event During the Entire Study Period
To compare the percentages of subjects presenting at least one serious adverse event (SAE) through 6 months post-final dose in subjects who received MenACWY-CRM197 vaccine concomitantly with routine vaccinations to the percentages of subjects who received routine vaccinations alone.
Time frame: Day 1 (2 months of age) to 18 months of age
Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination
To compare the percentage of subjects who reported local and systemic solicited adverse events from day 1 to day 7 after each vaccination with MenACWY-CRM197 given concomitantly with routine vaccinations to the routine vaccinations alone group.
Time frame: 15 minutes to Day 7
Number of Subjects Who Reported Unsolicited Adverse Events After Any Vaccination
Safety data with medically attended events were collected throughout the study in the non-detailed safety groups and from Day 8 onwards for the detailed safety groups.
Time frame: Day 1 (2 months of age) to 18 months of age
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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.
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