V260 Study: Concomitant Use of V260 and INFANRIX™ Hexa in Healthy Infants (V260-010)

NCT00258154 | Completed Phase 3 Results

• 2 other identifiers: V260-0102005_046
• Study Type: interventional
• Target: 403
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is being conducted to demonstrate that the vaccine to prevent gastroenteritis due to rotavirus may be administered concomitantly with INFANRIX(tm)hexa without impairing the safety and immunogenicity of either vaccine.

Conditions

Rotavirus Disease

Outcome Measures

Primary Outcomes (4)

• Immunogenicity of INFANRIX™ Hexa in Relation to Anti-hepatitis B Surface Antigen HBsAg, Predose 1

  Geometric Mean Titer (GMT)/antibody responses to RotaTeq™ and INFANRIX™ in relation to anti-hepatitis B surface antigen HBsAg at start of a 3-dose regimen

  Day 1 of a 3-dose regimen

• Immunogenicity of INFANRIX™ Hexa in Relation to Anti-hepatitis B Surface Antigen HBsAg , at 42 Days After a 3-dose Regimen

  GMT/antibody responses to RotaTeq™ and INFANRIX™ in relation to anti-hepatitis B surface antigen HBsAg at 42 days after 3-dose regimen

  42 days after 3-dose regimen

• Immunogenicity of INFANRIX™ Hexa in Relation to Serum Anti-polyribosylribitol Phosphate PRP, Predose 1

  GMT/antibody responses to RotaTeq™ and INFANRIX™ hexa in relation to serum anti-polyribosylribitol phosphate PRP at start of 3-dose regimen

  Day 1 of 3-dose regimen

• Immunogenicity of INFANRIX™ Hexa in Relation to Serum Anti-polyribosylribitol Phosphate PRP at 42 Days After a 3-dose Regimen

  GMT/antibody responses to RotaTeq™ and INFANRIX™ hexa in relation to serum anti-polyribosylribitol phosphate PRP at 42 days after a 3-dose regimen

  42 days after a 3-dose regimen

Secondary Outcomes (28)

• Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 1 When Administered Concomitantly With RotaTeq™, Predose 1

  Predose (Day 1 of a 3-dose regimen)

• Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 1 When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen

  42 days after a 3-dose regimen

• Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 2 When Administered Concomitantly With RotaTeq™, Predose 1

  Pre-dose (Day 1 of a 3-dose regimen)

• Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 2 When Administered Concomitantly With RotaTeq™, 42 Days After a 3-dose Regimen

  42 days after in a 3-dose regimen

• Immunogenicity of INFANRIX™ Hexa in Relation to Serum Antibody Levels to Poliovirus Type 3 When Administered Concomitantly With RotaTeq™, Predose 1

  Predose (Day 1 of a 3-dose regimen)

Study Arms (2)

1

EXPERIMENTAL

RotaTeq/Infanrix Hexa

Biological: Rotavirus Vaccine, Live, Oral, Pentavalent; Biological: Comparator: Infanrix(tm) Hexa

2

PLACEBO COMPARATOR

Placebo/Infanrix Hexa

Biological: Comparator: placebo; Biological: Comparator: Infanrix(tm) Hexa

Interventions

Rotavirus Vaccine, Live, Oral, Pentavalent BIOLOGICAL

3 doses of rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 42 days post dose 1 and 28 to 42 days post dose 2

1

Comparator: placebo BIOLOGICAL

3 doses of placebo to rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 42 days post dose 1 and 28 to 42 days post dose 2

2

Comparator: Infanrix(tm) Hexa BIOLOGICAL

3 doses of oral Infanrix(tm) Hexa on Day 1, 28 to 42 days post dose 1 and 28 to 42 days post dose 2

1; 2

Eligibility Criteria

• Age: 6 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infant per investigator, 6 through 12 weeks of age

You may not qualify if:

• History of congenital abdominal disorders, intussusception, or abdominal surgery
• Known or suspected impairment of immunological function
• Known hypersensitivity to any component of the rotavirus vaccine
• Prior administration of any rotavirus vaccine
• Known hypersensitivity or contraindication to any component of INFANRIX(tm) hexa
• Any infant born from a known HBsAg-positive mother
• Prior administration of any oral polio vaccine
• Receipt of one or more doses of inactivated poliovirus vaccine, diptheria, tetanus and acellular pertussis vaccine, diptheria, tetanus and pertussis vaccine, Haemophilus influenzae type b vaccine, or any hepatitis B vaccine prior to the first vaccination, or receipt of any vaccines with these antigens at any time during the course of the study
• Fever, with a rectal temperature greater than or equal to 38.1 degree C (greater than or equal to 100.5 degree F) at the time of immunization
• History of known prior rotavirus gastroenteritis, chronic diarrhea, or failure to thrive
• Clinical evidence of active gastrointestinal illness
• Receipt of intramuscular, oral, or intravenous corticosteroid treatment within the 2 weeks prior to vaccination
• Infants residing in a household with an immunocompromised person
• Prior receipt of a blood transfusion or blood products
• Participation in another clinical study within 42 days before the beginning or anytime during the duration of the current clinical study

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Ciarlet M, He S, Lai S, Petrecz M, Yuan G, Liu GF, Mikviman E, Heaton PM, Panzer F, Rose T, Koller DY, Van Damme P, Schodel F. Concomitant use of the 3-dose oral pentavalent rotavirus vaccine with a 3-dose primary vaccination course of a diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio-Haemophilus influenzae type b vaccine: immunogenicity and reactogenicity. Pediatr Infect Dis J. 2009 Mar;28(3):177-81. doi: 10.1097/INF.0b013e31818c0161.

  PMID: 19209092 RESULT

MeSH Terms

Conditions

Rotavirus Infections

Interventions

Rotavirus Vaccines; Acetylglucosaminidase

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; beta-N-Acetylhexosaminidases; Hexosaminidases; Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes

Results Point of Contact

• Title: Executive Vice President, Clinical and Quantitative Sciences
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2005
• First Posted: November 24, 2005
• Study Start: February 1, 2006
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: October 6, 2015
• Results First Posted: September 23, 2009

Record last verified: 2015-10