Bacterial InfectionsPhase 3NCT01337167

Safety, Tolerability, and Immunogenicity of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-005)

A Phase 3 study testing V419, DAPTACEL™ and PedvaxHIB™ in people with Bacterial Infections and Virus Diseases, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 46 to 89 daysHealthy volunteers can take part
Conditions the study is for: Bacterial Infections, Virus Diseases
What is being tested?: V419, DAPTACEL™ and PedvaxHIB™
Type of treatment: Vaccines, Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,473 participants
Where: No sites listed yet
Study dates: 19 Apr 2011to 9 May 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 46 to 89 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Participant is a healthy infant
Participant has received one dose of monovalent hepatitis B vaccine prior to or at 1 month of age

Who cannot join

Participant has received more than one dose of monovalent hepatitis B vaccine or hepatitis B based combination vaccine prior to study entry
Participant has been vaccinated with any acellular pertussis or whole cell pertussis based combination vaccines, haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate or pneumococcal polysaccharide, rotavirus, or any combination of the above
Participant has had a fever ≥38.0°C (≥110.4°F) within 24 hours of study enrollment
Participant was vaccinated with any non-study vaccine (i.e., inactivated, conjugated, live virus vaccine) within 30 days prior to study enrollment, except for inactivated influenza vaccine which will be permitted 15 days or more prior to enrollment
Participant has hepatitis B surface antigen (HBsAg) seropositivity (by medical history)
Participant has a history of haemophilus influenzae type B, hepatitis B, diphtheria, tetanus, pertussis, poliomyelitis, rotavirus, or pneumococcal infection

About this study

Official title: 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™

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.

Conditions: Bacterial Infections, Virus Diseases
Being tested: V419, DAPTACEL™, PedvaxHIB™, Prevnar 13™, RotaTeq™
Keywords: Diphtheria, Tetanus, Whooping Cough (pertussis), Poliomyelitis, Hepatitis B infection, Haemophilus influenzae type b infection
Medical subject headings: Bacterial Infections, Virus Diseases, Diphtheria, Tetanus, Whooping Cough, Poliomyelitis, Hepatitis B, Haemophilus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

V419Biological
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™Biological
DAPTACEL™ 0.5 mL intramuscular injection at 15 months of age
PedvaxHIB™Biological
PedvaxHIB™ 0.5 mL intramuscular injection at 15 months of age
Prevnar 13™Biological
Prevnar 13™ 0.5 mL intramuscular injection at 2, 4, 6, and 15 months of age
RotaTeq™Biological
Also called V260
RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age
PENTACEL™Biological
PENTACEL™ 0.5 mL intramuscular injection at 2, 4, and 6 months of age
Recombivax HB vaccineBiological
Recombivax HB vaccine 0.5 mL intramuscular injection at 2 and 6 months of age
ActHIB™Biological
ActHIB™ 0.5 mL intramuscular injection at 15 months of age

Study groups in NCT01337167
Study group	Role	What they receive
V419	Experimental	V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age. Receives: Biological: V419; Biological: DAPTACEL™; Biological: PedvaxHIB™; Biological: Prevnar 13™; Biological: RotaTeq™
Control	Active comparator	Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age. Receives: Biological: DAPTACEL™; Biological: Prevnar 13™; Biological: RotaTeq™; Biological: PENTACEL™; Biological: Recombivax HB vaccine; Biological: ActHIB™

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen
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.
Measured: Postdose 3 (Month 7)
Percentage of Participants Responding to Hepatitis B Surface Antigen
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.
Measured: Postdose 3 (Month 7)
Percentage of Participants Responding to Diphtheria Toxin
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.
Measured: Postdose 3 (Month 7)
Percentage of Participants Responding to Tetanus Toxin
Participant serum samples were collected for testing with an ELISA for anti-tetanus antibodies. Response was defined as a titer >=0.1 IU/mL.
Measured: Postdose 3 (Month 7)
Percentage of Participants Responding to Pertussis Toxin
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.
Measured: Postdose 3 (Month 7)
Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin
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.
Measured: Postdose 3 (Month 7)
Percentage of Participants Responding to Pertussis Pertactin
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.
Measured: Postdose 3 (Month 7)
Percentage of Participants Responding to Pertussis Fimbriae
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.
Measured: Postdose 3 (Month 7)
Percentage of Participants Responding to Poliovirus Type 1
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.
Measured: Postdose 3 (Month 7)
Percentage of Participants Responding to Poliovirus Type 2
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.
Measured: Postdose 3 (Month 7)
Percentage of Participants Responding to Poliovirus Type 3
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.
Measured: Postdose 3 (Month 7)
Geometric Mean Concentration of Antibodies to Pertussis Toxin
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).
Measured: Postdose 3 (Month 7)
Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin.
Measured: Postdose 3 (Month 7)
Geometric Mean Concentration of Antibodies to Pertussis Pertactin
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.
Measured: Postdose 3 (Month 7)
Geometric Mean Concentration of Antibodies to Pertussis Fimbriae
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.
Measured: Postdose 3 (Month 7)
Percentage of Participants Responding to Pertussis Toxin
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.
Measured: Postdose 4 (Month 16)
Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin
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.
Measured: Postdose 4 (Month 16)
Percentage of Participants Responding to Pertussis Pertactin
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.
Measured: Postdose 4 (Month 16)
Percentage of Participants Responding to Pertussis Fimbriae
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.
Measured: Postdose 4 (Month 16)
Geometric Mean Concentration of Antibodies to Pertussis Toxin
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin.
Measured: Postdose 4 (Month 16)
Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin.
Measured: Postdose 4 (Month 16)
Geometric Mean Concentration of Antibodies to Pertussis Pertactin
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.
Measured: Postdose 4 (Month 16)
Geometric Mean Concentration of Antibodies to Pertussis Fimbriae
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.
Measured: Postdose 4 (Month 16)

Secondary outcomes (8)

Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen
Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate.
Measured: Postdose 3 (Month 7)
Geometric Mean Concentration of Immunoglobulin A (IgA) Antibodies to Rotavirus
Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent assay for IgA antibodies to rotavirus.
Measured: Postdose 3 (Month 7)
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions
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.
Measured: Up to 5 days after any infant vaccination (up to 6 months)
Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
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.
Measured: Up to 5 days after any infant vaccination (up to 6 months)
Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
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.
Measured: Up to 5 days after each infant vaccination (up to 6 months)
Percentage of Participants With Elevated Temperature by Severity
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.
Measured: Up to 5 days after any infant vaccination (up to 6 months)
Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion
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.
Measured: Up to 15 days after any infant vaccination (up to 6 months)
Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion
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.
Measured: Up to 181 days after any infant vaccination (up to 12 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Apr 20119 May 2013

First posted18 Apr 2011 (estimated)
Study start19 Apr 2011
Primary completion9 May 2013
Study completion9 May 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,473 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01337167
Sponsor's protocol ID: V419-005
Status last verified: Oct 2018
First submitted: 15 Apr 2011
Last updated: 15 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Marshall GS, Adams GL, Leonardi ML, Petrecz M, Flores SA, Ngai AL, Xu J, Liu G, Stek JE, Foglia G, Lee AW. Immunogenicity, Safety, and Tolerability of a Hexavalent Vaccine in Infants. Pediatrics. 2015 Aug;136(2):e323-32. doi: 10.1542/peds.2014-4102.
PubMed 26216331

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruitingPhase 2
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
Pneumococcal Disease
Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
RecruitingObservational study
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Staphylococcal Infections

All Bacterial Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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™
ClinicalTrials.gov ID: NCT01337167
Acronym / sponsor ID: V419-005
Conditions: Bacterial Infections, Virus Diseases
Keywords: Diphtheria, Tetanus, Whooping Cough (pertussis), Poliomyelitis, Hepatitis B infection, Haemophilus influenzae type b infection
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,473 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Collaborators: MCM Vaccines B.V.
Study start: 19 Apr 2011 (actual)
Primary completion: 9 May 2013 (actual)
Study completion: 9 May 2013 (actual)
First posted: 18 Apr 2011 (estimated)
Results: Posted 16 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
V419	Experimental	Biological: V419, Biological: DAPTACEL™, Biological: PedvaxHIB™, Biological: Prevnar 13™, Biological: RotaTeq™V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
Control	Active comparator	Biological: DAPTACEL™, Biological: Prevnar 13™, Biological: RotaTeq™, Biological: PENTACEL™, Biological: Recombivax HB vaccine, Biological: ActHIB™Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.

Who may qualify

Ages: 46 to 89 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (2 listed)

Participant is a healthy infant
Participant has received one dose of monovalent hepatitis B vaccine prior to or at 1 month of age

Key exclusion criteria (6 listed)

Participant has received more than one dose of monovalent hepatitis B vaccine or hepatitis B based combination vaccine prior to study entry
Participant has been vaccinated with any acellular pertussis or whole cell pertussis based combination vaccines, haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate or pneumococcal polysaccharide, rotavirus, or any combination of the above
Participant has had a fever ≥38.0°C (≥110.4°F) within 24 hours of study enrollment
Participant was vaccinated with any non-study vaccine (i.e., inactivated, conjugated, live virus vaccine) within 30 days prior to study enrollment, except for inactivated influenza vaccine which will be permitted 15 days or more prior to enrollment
Participant has hepatitis B surface antigen (HBsAg) seropositivity (by medical history)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
V419V419 (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	Biological	V419
DAPTACEL™DAPTACEL™ 0.5 mL intramuscular injection at 15 months of age	Biological	Control, V419
PedvaxHIB™PedvaxHIB™ 0.5 mL intramuscular injection at 15 months of age	Biological	V419
Prevnar 13™Prevnar 13™ 0.5 mL intramuscular injection at 2, 4, 6, and 15 months of age	Biological	Control, V419
RotaTeq™Also: V260RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age	Biological	Control, V419
PENTACEL™PENTACEL™ 0.5 mL intramuscular injection at 2, 4, and 6 months of age	Biological	Control
Recombivax HB vaccineRecombivax HB vaccine 0.5 mL intramuscular injection at 2 and 6 months of age	Biological	Control
ActHIB™ActHIB™ 0.5 mL intramuscular injection at 15 months of age	Biological	Control

Primary outcome

Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen
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.
Percentage of Participants Responding to Hepatitis B Surface Antigen
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.
Percentage of Participants Responding to Diphtheria Toxin
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.
Percentage of Participants Responding to Tetanus Toxin
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.
Percentage of Participants Responding to Pertussis Toxin
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.
Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin
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.
Percentage of Participants Responding to Pertussis Pertactin
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.
Percentage of Participants Responding to Pertussis Fimbriae
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.
Percentage of Participants Responding to Poliovirus Type 1
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.
Percentage of Participants Responding to Poliovirus Type 2
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.
Percentage of Participants Responding to Poliovirus Type 3
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.
Geometric Mean Concentration of Antibodies to Pertussis Toxin
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).
Geometric Mean Concentration of 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 filamentous hemagglutinin.
Geometric Mean Concentration of Antibodies to Pertussis Pertactin
Time frame: Postdose 3 (Month 7)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.
Geometric Mean Concentration of Antibodies to Pertussis Fimbriae
Time frame: Postdose 3 (Month 7)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.
Percentage of Participants Responding to Pertussis Toxin
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.
Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin
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.
Percentage of Participants Responding to Pertussis Pertactin
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.
Percentage of Participants Responding to Pertussis Fimbriae
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.
Geometric Mean Concentration of Antibodies to Pertussis Toxin
Time frame: Postdose 4 (Month 16)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin.
Geometric Mean Concentration of 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 filamentous hemagglutinin.
Geometric Mean Concentration of Antibodies to Pertussis Pertactin
Time frame: Postdose 4 (Month 16)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.
Geometric Mean Concentration of Antibodies to Pertussis Fimbriae
Time frame: Postdose 4 (Month 16)
Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.

8 secondary outcomes

Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen
Time frame: Postdose 3 (Month 7)
Geometric Mean Concentration of Immunoglobulin A (IgA) Antibodies to Rotavirus
Time frame: Postdose 3 (Month 7)
Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions
Time frame: Up to 5 days after any infant vaccination (up to 6 months)
Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
Time frame: Up to 5 days after any infant vaccination (up to 6 months)
Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug
Time frame: Up to 5 days after each infant vaccination (up to 6 months)
Percentage of Participants With Elevated Temperature by Severity
Time frame: Up to 5 days after any infant vaccination (up to 6 months)
Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion
Time frame: Up to 15 days after any infant vaccination (up to 6 months)
Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion
Time frame: Up to 181 days after any infant vaccination (up to 12 months)

Results and safety

Results posted to the registry on 16 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
V419	986	924
Control	487	460

Primary outcome: Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen

Time frame: Postdose 3 (Month 7). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	V419 n = 765	Control n = 382
Titer >=1.0 μg/mL	84.97 (82.24 to 87.43)	75.39 (70.76 to 79.63)
Titer >=0.15 μg/mL	97.25 (95.83 to 98.29)	92.41 (89.28 to 94.86)

V419 vs Control: Response Rate Difference (V419 - Ctrl): 9.68 (95% CI 4.83 to 14.83), p <0.001, Miettinen and Nurminen
V419 vs Control: Response Rate Difference (V419 - Ctrl): 4.87 (95% CI 2.23 to 8.14), p <0.001, Miettinen and Nurminen
V419 vs Control: Response Rate Difference (V419-Ctrl): 4.87 (95% CI 2.23 to 8.14), p <0.001, Miettinen and Nurminen

Population analysed: The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.

Primary outcome: Percentage of Participants Responding to Hepatitis B Surface Antigen

Time frame: Postdose 3 (Month 7). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	V419 n = 688	Control n = 353
Value	99.42 (98.52 to 99.84)	98.58 (96.73 to 99.54)

V419 vs Control: Response Rate Difference (V419 - Ctrl): 0.84 (95% CI -0.35 to 2.74), p <0.001, Miettinen and Nurminen

Primary outcome: Percentage of Participants Responding to Diphtheria Toxin

Time frame: Postdose 3 (Month 7). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	V419 n = 786	Control n = 393
Value	82.44 (79.60 to 85.04)	86.26 (82.45 to 89.51)

V419 vs Control: Response Rate Difference (V419 - Ctrl): -3.84 (95% CI -8.02 to 0.66), p = 0.002, Miettinen and Nurminen

Primary outcome: Percentage of Participants Responding to Tetanus Toxin

Time frame: Postdose 3 (Month 7). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	V419 n = 787	Control n = 390
Value	99.87 (99.29 to 100.00)	99.49 (98.16 to 99.94)

V419 vs Control: Response Rate Difference (V419 - Ctrl): 0.39 (95% CI -0.28 to 1.74), p <0.001, Miettinen and Nurminen

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
V419	58 of 980 (5.9%)	939 of 980 (95.8%)	Not reported
Control	32 of 483 (6.6%)	458 of 483 (94.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26216331Marshall GS, Adams GL, Leonardi ML, Petrecz M, Flores SA, Ngai AL, Xu J, Liu G, Stek JE, Foglia G, Lee AW. Immunogenicity, Safety, and Tolerability of a Hexavalent Vaccine in Infants. Pediatrics. 2015 Aug;136(2):e323-32. doi: 10.1542/peds.2014-4102.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing V419, DAPTACEL™ and PedvaxHIB™ in people with Bacterial Infections and Virus Diseases, run by Merck Sharp & Dohme LLC.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen (time frame: Postdose 3 (Month 7)). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01337167, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2018.