NCT01341639

Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007)

A Phase III Randomized, Double-Blind, Active-Comparator Controlled Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4, and 12 Months (V419-007-03)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,250 (actual)
• Sponsor: MCM Vaccines B.V. · Industry
• Sex: All
• Age: 46 Days – 74 Days
• Healthy volunteers: Accepted

Summary

This study will determine whether participants who receive the vaccine V419 at 2, 3, 4, and 12 months of age have an acceptable immune response to the vaccine. The study will also determine whether the immune response to V419 is similar to that of participants who receive a licensed vaccine control.

Conditions

• Bacterial Infections
• Virus Diseases

Interventions

Type	Name	Description
BIOLOGICAL	V419	V419 (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate \[Meningococcal Outer Membrane Protein Complex\], and Hepatitis B \[Recombinant\] Vaccine) 0.5 mL intramuscular injection at 2, 3, 4, and 12 months of age.
BIOLOGICAL	INFANRIX™ hexa	INFANRIX™ hexa 0.5 mL intramuscular injection at 2, 3, 4, and 12 months of age.
BIOLOGICAL	RotaTeq	RotaTeq (pentavalent combination live vaccine of 5 human-bovine reassortant rotavirus strains) 2 mL oral dose at 2, 3, and 4 months of age
BIOLOGICAL	Prevenar 13	Prevenar 13 0.5 mL intramuscular injection at 2, 3, 4,and 13 months of age
BIOLOGICAL	ProQuad™	ProQuad™ 0.5 mL subcutaneous injection at 12 and 13 months of age

Timeline

• Start date: 2011-05-26
• Primary completion: 2013-03-13
• Completion: 2013-03-13
• First posted: 2011-04-26
• Last updated: 2019-04-30
• Results posted: 2019-04-10