Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007)
This study has been completed.
Sponsor:
Sanofi Pasteur MSD
Collaborator:
Merck
Information provided by (Responsible Party):
Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:
NCT01341639
First received: April 22, 2011
Last updated: April 9, 2013
Last verified: April 2013
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Purpose
This study will determine whether subjects who receive 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 subjects who receive a licensed vaccine control.
| Condition | Intervention | Phase |
|---|---|---|
|
Bacterial Infections Virus Diseases |
Biological: V419 Biological: INFANRIX hexa Biological: RotaTeq Biological: Prevenar 13 Biological: ProQuad |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | 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) |
Resource links provided by NLM:
MedlinePlus related topics:
Bacterial Infections
Diphtheria
Hepatitis
Hepatitis A
Hepatitis B
Tetanus
Whooping Cough
Drug Information available for:
Boostrix
Heptavalent pneumococcal conjugate vaccine
Rotarix
Adacel
Pneumococcal Vaccines
U.S. FDA Resources
Further study details as provided by Sanofi Pasteur MSD:
Primary Outcome Measures:
- Number of responders to polyribosylribitol phosphate (PRP) antigen [ Time Frame: Post-dose 3 (5 Months) ] [ Designated as safety issue: No ]
- Number of responders to diphtheria antigen [ Time Frame: Post-dose 3 (5 Months) ] [ Designated as safety issue: No ]
- Number of responders to tetanus antigen [ Time Frame: Post-dose 3 (5 Months) ] [ Designated as safety issue: No ]
- Number of responders to inactivated poliovirus (IPV) antigen [ Time Frame: Post-dose 3 (5 Months) ] [ Designated as safety issue: No ]
- Number of responders to polyribosylribitol phosphate (PRP) antigen [ Time Frame: Post-dose 4 (13 Months) ] [ Designated as safety issue: No ]
- Number of responders to diphtheria antigen [ Time Frame: Post-dose 4 (13 Months) ] [ Designated as safety issue: No ]
- Number of responders to tetanus antigen [ Time Frame: Post-dose 4 (13 Months) ] [ Designated as safety issue: No ]
- Number of responders to inactivated poliovirus (IPV) antigen [ Time Frame: Post-dose 4 (13 Months) ] [ Designated as safety issue: No ]
- Number of responders to hepatitis B surface antigen (HBsAg) [ Time Frame: Post-dose 4 (13 Months) ] [ Designated as safety issue: No ]
- Number of responders to pertussis antigens [ Time Frame: Post-dose 4 (Month 13) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of responders to measles antigen [ Time Frame: Post-dose 4 (13 Months) ] [ Designated as safety issue: No ]
- Number of responders to mumps antigen [ Time Frame: Post-dose 4 (13 Months) ] [ Designated as safety issue: No ]
- Number of responders to rubella antigen [ Time Frame: Post-dose 4 (13 Months) ] [ Designated as safety issue: No ]
- Number of responders to varicella antigen [ Time Frame: Post-dose 4 (13 Months) ] [ Designated as safety issue: No ]
| Enrollment: | 1250 |
| Study Start Date: | May 2011 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: V419
V419 + RotaTeq + Prevenar 13 + ProQuad
|
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: RotaTeq
RotaTeq 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
|
|
Active Comparator: INFANRIX hexa
INFANRIX hexa + RotaTeq + Prevenar 13 + ProQuad
|
Biological: INFANRIX hexa
INFANRIX™ hexa 0.5 mL intramuscular injection at 2, 3, 4, and 12 months of age.
Biological: RotaTeq
RotaTeq 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
|
Eligibility| Ages Eligible for Study: | 46 Days to 74 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01341639
Locations
| Belgium | |
| SPMSD Investigational Site 0070001 | |
| Antwerpen, Belgium | |
| SPMSD Investigational Site 0070002 | |
| Hasselt, Belgium | |
| Finland | |
| SPMSD Investigational Site 0070011 | |
| Espoo, Finland | |
| SPMSD Investigational Site 0070008 | |
| Helsinki, Finland | |
| SPMSD Investigational Site 0070010 | |
| Helsinki, Finland | |
| SPMSD Investigational Site 0070006 | |
| Jarvenpaa, Finland | |
| SPMSD Investigational Site 0070045 | |
| Kokkola, Finland | |
| SPMSD Investigational Site 0070007 | |
| Lahti, Finland | |
| SPMSD Investigational Site 0070012 | |
| Oulu, Finland | |
| SPMSD Investigational Site 0070005 | |
| Pori, Finland | |
| SPMSD Investigational Site 0070013 | |
| Seinajoki, Finland | |
| SPMSD Investigational Site 0070003 | |
| Tampere, Finland | |
| SPMSD Investigational Site 0070004 | |
| Turku, Finland | |
| SPMSD Investigational Site 0070009 | |
| Vantaa, Finland | |
| Germany | |
| SPMSD Investigational Site 0070051 | |
| Aalen, Germany | |
| SPMSD Investigational Site 0070016 | |
| Alsfeld, Germany | |
| SPMSD Investigational Site 0070036 | |
| Aschaffenburg, Germany | |
| SPMSD Investigational Site 0070018 | |
| Baunatal, Germany | |
| SPMSD Investigational Site 0070039 | |
| Berlin, Germany | |
| SPMSD Investigational Site 0070015 | |
| Bochum, Germany | |
| SPMSD Investigational Site 0070033 | |
| Bonnigheim, Germany | |
| SPMSD Investigational Site 0070014 | |
| Bramsche, Germany | |
| SPMSD Investigational Site 0070029 | |
| Bretten, Germany | |
| SPMSD Investigational Site 0070038 | |
| Datteln, Germany | |
| SPMSD Investigational Site 0070024 | |
| Erfurt, Germany | |
| SPMSD Investigational Site 0070048 | |
| Fulda, Germany | |
| SPMSD Investigational Site 0070049 | |
| Hagen, Germany | |
| SPMSD Investigational Site 0070026 | |
| Hamburg, Germany | |
| SPMSD Investigational Site 0070020 | |
| Herbolzheim, Germany | |
| SPMSD Investigational Site 0070052 | |
| Herford, Germany | |
| SPMSD Investigational Site 0070019 | |
| Karlsruhe, Germany | |
| SPMSD Investigational Site 0070041 | |
| Kleve-Materborn, Germany | |
| SPMSD Investigational Site 0070034 | |
| Mannheim, Germany | |
| SPMSD Investigational Site 0070042 | |
| Marbach, Germany | |
| SPMSD Investigational Site 0070030 | |
| Monchengladbach, Germany | |
| SPMSD Investigational Site 0070022 | |
| Monchengladbach, Germany | |
| SPMSD Investigational Site 0070050 | |
| Neumunster, Germany | |
| SPMSD Investigational Site 0070031 | |
| Oberhausen, Germany | |
| SPMSD Investigational Site 0070053 | |
| Schwäbisch Hall, Germany | |
| SPMSD Investigational Site 0070023 | |
| Solingen, Germany | |
| SPMSD Investigational Site 0070025 | |
| Stockelsdorf, Germany | |
| SPMSD Investigational Site 0070035 | |
| Stuttgart, Germany | |
| SPMSD Investigational Site 0070032 | |
| Tuttlingen, Germany | |
| SPMSD Investigational Site 0070037 | |
| Welzheim, Germany | |
Sponsors and Collaborators
Sanofi Pasteur MSD
Merck
More Information
No publications provided
| Responsible Party: | Sanofi Pasteur MSD |
| ClinicalTrials.gov Identifier: | NCT01341639 History of Changes |
| Other Study ID Numbers: | V419-007, 2010-021490-37 |
| Study First Received: | April 22, 2011 |
| Last Updated: | April 9, 2013 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products Finland: Finnish Medicines Agency Germany: Paul-Ehrlich-Institut |
Keywords provided by Sanofi Pasteur MSD:
|
combination vaccine diphtheria pertussis tetanus hepatitis B |
Hep B Haemophilus influenzae b Hib polio poliovirus |
Additional relevant MeSH terms:
|
Bacterial Infections Virus Diseases |
ClinicalTrials.gov processed this record on May 23, 2013