NCT Number: NCT01337167
This is a study to assess the safety, tolerability, and immunogenicity of V419 (PR5I) when administered as an infant series at 2, 4, and 6 months of age followed by a toddler dose of DAPTACEL™, Prevnar 13™ and PedvaxHIB™ at 15 months of age. The study will determine whether subjects who receive V419 have a similar immune response to the vaccine compared to subjects who receive licensed component vaccine controls.
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Notify Me46 day–89 day
All sexes
Interventional
Phase 3
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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, 4, and 6 months of age
DAPTACEL™ 0.5 mL intramuscular injection at 15 months of age
PedvaxHIB™ 0.5 mL intramuscular injection at 15 months of age
Prevnar 13™ 0.5 mL intramuscular injection at 2, 4, 6, and 15 months of age
RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age
Other names: V260
PENTACEL™ 0.5 mL intramuscular injection at 2, 4, and 6 months of age
Recombivax HB vaccine 0.5 mL intramuscular injection at 2 and 6 months of age
ActHIB™ 0.5 mL intramuscular injection at 15 months of age
Time frame: Postdose 3 (Month 7)
Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate. Response was evaluated for titer >=0.15 μg/mL and >=1.0 μg/mL.
Time frame: Postdose 3 (Month 7)
Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to Hepatitis B Surface Antigen. Response was defined as a titer >=10 milli International units (mIU)/mL.
Time frame: Postdose 3 (Month 7)
Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to diphtheria toxin. Response was defined as a titer >=0.1 International unit (IU)/mL.
Time frame: Postdose 3 (Month 7)
Participant serum samples were collected for testing with an ELISA for anti-tetanus antibodies. Response was defined as a titer >=0.1 IU/mL.
Time frame: Postdose 3 (Month 7)
Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was <4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.
Time frame: Postdose 3 (Month 7)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.
Time frame: Postdose 3 (Month 7)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.
Time frame: Postdose 3 (Month 7)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was <4X LLOQ then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.
Time frame: Postdose 3 (Month 7)
Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 1. Response is defined as a titer >=8.
Time frame: Postdose 3 (Month 7)
Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2. Response is defined as a titer >=8.
Time frame: Postdose 3 (Month 7)
Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 3. Response is defined as a titer >=8.
Time frame: Postdose 3 (Month 7)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. The unit of measure is ELISA units/mL (EU/mL).
Time frame: Postdose 3 (Month 7)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin.
Time frame: Postdose 3 (Month 7)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.
Time frame: Postdose 3 (Month 7)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.
Time frame: Postdose 4 (Month 16)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was <4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.
Time frame: Postdose 4 (Month 16)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was <4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.
Time frame: Postdose 4 (Month 16)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was <4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.
Time frame: Postdose 4 (Month 16)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was <4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was >=4X LLOQ; 2) if the predose titer was >=4X LLOQ then the postdose titer was >= the predose titer.
Time frame: Postdose 4 (Month 16)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin.
Time frame: Postdose 4 (Month 16)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin.
Time frame: Postdose 4 (Month 16)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.
Time frame: Postdose 4 (Month 16)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.
Time frame: Postdose 3 (Month 7)
Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate.
Time frame: Postdose 3 (Month 7)
Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent assay for IgA antibodies to rotavirus.
Time frame: Up to 5 days after any infant vaccination (up to 6 months)
Solicited injection-site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Pyrexia, Vomiting, Crying abnormal, Somnolence, Decreased appetite, and Irritability. Grade 3 Solicited injection site reaction: Pain, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, >5 cm. Grade 3 Solicited systemic reactions: Pyrexia, >=39.5°C (>=103.1°F) rectal; Vomiting, >=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Decreased appetite, Refuses >=3 feeds or refuses most feeds; Irritability, Inconsolable.
Time frame: Up to 5 days after any infant vaccination (up to 6 months)
Solicited systemic adverse events: pyrexia, vomiting, crying abnormal, somnolence, decreased appetite, and irritability. Adverse events deemed related to study drug were those judged to be definitely related, probably related, or possibly related by the investigator.
Time frame: Up to 5 days after each infant vaccination (up to 6 months)
Solicited systemic adverse events: pyrexia, vomiting, crying abnormal, somnolence, decreased appetite, and irritability. Adverse events deemed related to study drug were those judged to be definitely related, probably related, or possibly related by the investigator.
Time frame: Up to 5 days after any infant vaccination (up to 6 months)
Maximum temperature (all routes) was based on actual temperatures recorded with no adjustments to the measurement route. Maximum temperature (rectal) was required of all participants if the reading by another method was >=38.0°C.
Time frame: Up to 15 days after any infant vaccination (up to 6 months)
The percentage of participants with one or more adverse events (AE), serious adverse events (SAE), and vaccine-related SAE (pyrexia, febrile convulsion, and convulsion) is reported.
Time frame: Up to 181 days after any infant vaccination (up to 12 months)
The percentage of participants with one or more adverse events (AE), serious adverse events (SAE), and vaccine-related SAE (pyrexia, febrile convulsion, and convulsion) is reported.
Merck Sharp & Dohme LLC
Industry
A Phase III Randomized, Open-Label, Active-Comparator Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V419 in Infants When Given at 2, 4, and 6 Months Concomitantly With Prevnar 13™ and RotaTeq™
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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