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

NCT ID: NCT01341639

Last Updated: 2019-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-26
• Study Completion Date: 2013-03-13

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

PR5I

V419 + RotaTeq + Prevenar 13 + ProQuad

Group Type: EXPERIMENTAL

V419

Intervention Type: BIOLOGICAL

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.

RotaTeq

Intervention Type: BIOLOGICAL

RotaTeq (pentavalent combination live vaccine of 5 human-bovine reassortant rotavirus strains) 2 mL oral dose at 2, 3, and 4 months of age

Prevenar 13

Intervention Type: BIOLOGICAL

Prevenar 13 0.5 mL intramuscular injection at 2, 3, 4,and 13 months of age

ProQuad™

Intervention Type: BIOLOGICAL

ProQuad™ 0.5 mL subcutaneous injection at 12 and 13 months of age

INFANRIX™ hexa

INFANRIX™ hexa + RotaTeq + Prevenar 13 + ProQuad

Group Type: ACTIVE_COMPARATOR

INFANRIX™ hexa

Intervention Type: BIOLOGICAL

INFANRIX™ hexa 0.5 mL intramuscular injection at 2, 3, 4, and 12 months of age.

RotaTeq

Intervention Type: BIOLOGICAL

RotaTeq (pentavalent combination live vaccine of 5 human-bovine reassortant rotavirus strains) 2 mL oral dose at 2, 3, and 4 months of age

Prevenar 13

Intervention Type: BIOLOGICAL

Prevenar 13 0.5 mL intramuscular injection at 2, 3, 4,and 13 months of age

ProQuad™

Intervention Type: BIOLOGICAL

ProQuad™ 0.5 mL subcutaneous injection at 12 and 13 months of age

Interventions

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.

Intervention Type: BIOLOGICAL

INFANRIX™ hexa

INFANRIX™ hexa 0.5 mL intramuscular injection at 2, 3, 4, and 12 months of age.

Intervention Type: 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

Intervention Type: BIOLOGICAL

Prevenar 13

Prevenar 13 0.5 mL intramuscular injection at 2, 3, 4,and 13 months of age

Intervention Type: BIOLOGICAL

ProQuad™

ProQuad™ 0.5 mL subcutaneous injection at 12 and 13 months of age

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Healthy infants able to attend all study visits
• Parent(s)/legal representative able to read, understand, and complete study questionnaires

Exclusion Criteria

• History of congenital or acquired immunodeficiency
• Received or is expected to receive immunosuppressive agents or systemic immunomodulatory steroids
• History of leukemia, lymphoma, malignant melanoma, or myeloproliferative disorder
• Hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines or concomitant study vaccines
• Has any chronic illness that could interfere with study conduct or completion
• Received any immune globulin, blood, or blood-derived products since birth
• Received a dose of hepatitis B vaccine prior to the study
• Vaccinated with any acellular pertussis or whole cell pertussis based combination vaccines, Haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate or pneumococcal polysaccharide, rotavirus, measles, mumps, rubella, or varicella vaccines, or any combination thereof
• Fever within 24 hours prior to enrollment
• Received any non-study vaccine within 30 days prior to enrollment, except for inactivated influenza vaccine, which is permitted 14 days or more prior to enrollment
• Has a coagulation disorder
• Has developmental delay or neurological disorder
• Participant or his/her mother has a medical history of hepatitis B surface antigen (HBsAg) seropositivity
• History of measles, mumps, rubella, varicella, Haemophilus influenzae type B, hepatitis B, diphtheria, tetanus, pertussis, rotavirus, invasive pneumococcal, or poliomyelitis infection

• Minimum Eligible Age: 46 Days
• Maximum Eligible Age: 74 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

MCM Vaccines B.V.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Vesikari T, Becker T, Vertruyen AF, Poschet K, Flores SA, Pagnoni MF, Xu J, Liu GF, Stek JE, Boisnard F, Thomas S, Ziani E, Lee AW. A Phase III Randomized, Double-blind, Clinical Trial of an Investigational Hexavalent Vaccine Given at Two, Three, Four and Twelve Months. Pediatr Infect Dis J. 2017 Feb;36(2):209-215. doi: 10.1097/INF.0000000000001406.

Reference Type: DERIVED

PMID: 27846055 (View on PubMed)

Other Identifiers

2010-021490-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V419-007

Identifier Type: -

Identifier Source: org_study_id