Bacterial InfectionsPhase 3NCT01340937

A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006)

A Phase 3 study testing V419, PENTACEL™ and Prevnar 13™ 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

This study will determine whether three manufacturing lots of V419 (PR5I) induce similar immune responses to all of the antigens contained in V419 when given concomitantly with Prevnar13™ and RotaTeq™. Read more about this study

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, PENTACEL™ and Prevnar 13™
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: 2,808 participants
Where: No sites listed yet
Study dates: 10 May 2011to 26 Jul 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 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, measles, mumps, rubella, or varicella vaccines or any combination of the above
Participant has had an illness with fever within 24 hours of study enrollment
Participant was vaccinated with any non-study vaccine (i.e. inactivated, conjugated or live virus vaccine within 30 days prior to enrollment, except for inactivated influenza vaccine, which is permitted 15 days or more prior to enrollment
Participant or his/her mother 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, Partially Double-Blind, Active-Comparator-Controlled, Lot-to-Lot Consistency Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 6 Months Concomitantly With Prevnar 13™ and RotaTeq ™

Read the detailed description

This study is partially Double-Blinded in that the participants' parents/guardians, investigator/study site personnel, and Sponsor's representatives will be blinded to the lot of V419 the participant is randomized to receive, but not to the participant's treatment group (V419 or control).

Conditions: Bacterial Infections, Virus Diseases
Being tested: V419, PENTACEL™, Prevnar 13™, RotaTeq™, Recombivax HB vaccine
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) (from one of three lots) 0.5 mL intramuscular injection at 2, 4, and 6 months of age.
PENTACEL™Biological
PENTACEL™ 0.5 mL intramuscular injection at 15 months of age in the V419 groups and at 2, 4, 6, and 15 months of age in the control group
Prevnar 13™Biological
Prevnar 13™ 0.5 mL intramuscular injection at 2, 4, 6, and 15 months of age
RotaTeq™Biological
RotaTeq™ 2 mL oral dose 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

Study groups in NCT01340937
Study group	Role	What they receive
V419 Lot A	Experimental	V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 month 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: PENTACEL™; Biological: Prevnar 13™; Biological: RotaTeq™
V419 Lot B	Experimental	V419 (Lot B) 0.5 mL IM at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 month 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: PENTACEL™; Biological: Prevnar 13™; Biological: RotaTeq™
V419 Lot C	Experimental	V419 (Lot C) 0.5 mL IM at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 month 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: PENTACEL™; Biological: Prevnar 13™; Biological: RotaTeq™
Control	Active comparator	Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age Receives: Biological: PENTACEL™; Biological: Prevnar 13™; Biological: RotaTeq™; Biological: Recombivax HB vaccine

What is being measured

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

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 Antibodies to Hepatitis B Surface Antigen
Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to Hepatitis B Surface Antigen. The unit of measure is milli International Units/mL (mIU/mL).
Measured: Postdose 3 (Month 7)
Geometric Mean Concentration of Antibodies to Diphtheria Toxin
Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to diphtheria toxin. The unit of measure is International Units/mL (IU/mL).
Measured: Postdose 3 (Month 7)
Geometric Mean Concentration of Antibodies to Tetanus Toxin
Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for anti-tetanus antibodies.
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)
Geometric Mean Titer for Antibodies to Poliovirus Type 1
Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 1. The unit of measure is titer (reciprocal of highest dilution with neutralizing activity).
Measured: Postdose 3 (Month 7)
Geometric Mean Titer for Antibodies to Poliovirus Type 2
Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2.
Measured: Postdose 3 (Month 7)
Geometric Mean Titer for Antibodies to Poliovirus Type 3
Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 3.
Measured: Postdose 3 (Month 7)

Secondary outcomes (22)

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 a 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 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 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 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. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
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. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
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. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
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. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
Measured: Postdose 4 (Month 16)
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 <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. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
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 <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. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
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 <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. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
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 <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. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
Measured: Postdose 4 (Month 16)
Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes
Participant serum samples were collected for testing with a multiplex electrochemiluminescence-based detection assay for serotype-specific pneumococcal polysaccharide antibodies. Analysis for this outcome included only non-inferiority of V419 Lots A, B, and C Combined versus Control.
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: Fever, Vomiting, Crying abnormal, Drowsiness, Appetite lost, 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: Fever (Pyrexia), >=39.5°C rectal; Vomiting, >=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, >3 hours; Drowsiness (Somnolence), Sleeping most of the time or difficult to wake up; Appetite lost, 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 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)

Timeline

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

10 May 201126 Jul 2013

First posted25 Apr 2011 (estimated)
Study start10 May 2011
Primary completion18 Dec 2012
Study completion26 Jul 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 2,808 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01340937
Sponsor's protocol ID: V419-006
Status last verified: Oct 2018
First submitted: 21 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

Block SL, Klein NP, Sarpong K, Russell S, Fling J, Petrecz M, Flores S, Xu J, Liu G, Stek JE, Foglia G, Lee AW. Lot-to-lot Consistency, Safety, Tolerability and Immunogenicity of an Investigational Hexavalent Vaccine in US Infants. Pediatr Infect Dis J. 2017 Feb;36(2):202-208. doi: 10.1097/INF.0000000000001405.
PubMed 27846058

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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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, Partially Double-Blind, Active-Comparator-Controlled, Lot-to-Lot Consistency Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 6 Months Concomitantly With Prevnar 13™ and RotaTeq ™
ClinicalTrials.gov ID: NCT01340937
Acronym / sponsor ID: V419-006
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: 2,808 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Collaborators: MCM Vaccines B.V.
Study start: 10 May 2011 (actual)
Primary completion: 18 Dec 2012 (actual)
Study completion: 26 Jul 2013 (actual)
First posted: 25 Apr 2011 (estimated)
Results: Posted 2 May 2016

Clinical summary

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

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
V419 Lot A	Experimental	Biological: V419, Biological: PENTACEL™, Biological: Prevnar 13™, Biological: RotaTeq™V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 month 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
V419 Lot B	Experimental	Biological: V419, Biological: PENTACEL™, Biological: Prevnar 13™, Biological: RotaTeq™V419 (Lot B) 0.5 mL IM at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 month 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
V419 Lot C	Experimental	Biological: V419, Biological: PENTACEL™, Biological: Prevnar 13™, Biological: RotaTeq™V419 (Lot C) 0.5 mL IM at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 month 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: PENTACEL™, Biological: Prevnar 13™, Biological: RotaTeq™, Biological: Recombivax HB vaccinePentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 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 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, measles, mumps, rubella, or varicella vaccines or any combination of the above
Participant has had an illness with fever within 24 hours of study enrollment
Participant was vaccinated with any non-study vaccine (i.e. inactivated, conjugated or live virus vaccine within 30 days prior to enrollment, except for inactivated influenza vaccine, which is permitted 15 days or more prior to enrollment
Participant or his/her mother 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) (from one of three lots) 0.5 mL intramuscular injection at 2, 4, and 6 months of age.	Biological	V419 Lot A, V419 Lot B, V419 Lot C
PENTACEL™PENTACEL™ 0.5 mL intramuscular injection at 15 months of age in the V419 groups and at 2, 4, 6, and 15 months of age in the control group	Biological	Control, V419 Lot A, V419 Lot B, V419 Lot C
Prevnar 13™Prevnar 13™ 0.5 mL intramuscular injection at 2, 4, 6, and 15 months of age	Biological	Control, V419 Lot A, V419 Lot B, V419 Lot C
RotaTeq™RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age	Biological	Control, V419 Lot A, V419 Lot B, V419 Lot C
Recombivax HB vaccineRecombivax HB vaccine 0.5 mL intramuscular injection at 2 and 6 months of age	Biological	Control

Primary outcome

Geometric Mean Concentration of Antibodies 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.
Geometric Mean Concentration of Antibodies 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. The unit of measure is milli International Units/mL (mIU/mL).
Geometric Mean Concentration of Antibodies 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. The unit of measure is International Units/mL (IU/mL).
Geometric Mean Concentration of Antibodies to Tetanus Toxin
Time frame: Postdose 3 (Month 7)
Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for anti-tetanus antibodies.
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.
Geometric Mean Titer for Antibodies 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. The unit of measure is titer (reciprocal of highest dilution with neutralizing activity).
Geometric Mean Titer for Antibodies 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.
Geometric Mean Titer for Antibodies 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.

22 secondary outcomes

Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen
Time frame: Postdose 3 (Month 7)
Percentage of Participants Responding to Hepatitis B Surface Antigen
Time frame: Postdose 3 (Month 7)
Percentage of Participants Responding to Diphtheria Toxin
Time frame: Postdose 3 (Month 7)
Percentage of Participants Responding to Tetanus Toxin
Time frame: Postdose 3 (Month 7)
Percentage of Participants Responding to Pertussis Toxin
Time frame: Postdose 3 (Month 7)
Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin
Time frame: Postdose 3 (Month 7)
Percentage of Participants Responding to Pertussis Pertactin
Time frame: Postdose 3 (Month 7)
Percentage of Participants Responding to Pertussis Fimbriae
Time frame: Postdose 3 (Month 7)
Percentage of Participants Responding to Poliovirus Type 1
Time frame: Postdose 3 (Month 7)
Percentage of Participants Responding to Poliovirus Type 2
Time frame: Postdose 3 (Month 7)
Percentage of Participants Responding to Poliovirus Type 3
Time frame: Postdose 3 (Month 7)
Geometric Mean Concentration of Antibodies to Pertussis Toxin
Time frame: Postdose 4 (Month 16)
Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin
Time frame: Postdose 4 (Month 16)
Geometric Mean Concentration of Antibodies to Pertussis Pertactin
Time frame: Postdose 4 (Month 16)
Geometric Mean Concentration of Antibodies to Pertussis Fimbriae
Time frame: Postdose 4 (Month 16)
Percentage of Participants Responding to Pertussis Toxin
Time frame: Postdose 4 (Month 16)
Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin
Time frame: Postdose 4 (Month 16)
Percentage of Participants Responding to Pertussis Pertactin
Time frame: Postdose 4 (Month 16)
Percentage of Participants Responding to Pertussis Fimbriae
Time frame: Postdose 4 (Month 16)
Geometric Mean Concentration of Antibodies to Pneumococcal Serotypes
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 With Elevated Temperature by Severity
Time frame: Up to 5 days after any infant vaccination (up to 6 months)

Results and safety

Results posted to the registry on 2 May 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 Lot A	800	742
V419 Lot B	797	737
V419 Lot C	809	753
Control	402	370

Primary outcome: Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen

Time frame: Postdose 3 (Month 7). Geometric mean (95% Confidence Interval). Unit: µg/mL

Measure	V419 Lot A n = 604	V419 Lot B n = 596	V419 Lot C n = 595	Control n = 288	V419 Lots A, B, and C Combined n = 1795
Value	5.51 (4.88 to 6.21)	6.10 (5.38 to 6.92)	6.59 (5.80 to 7.47)	3.76 (3.11 to 4.55)	6.05 (5.63 to 6.50)

V419 Lot A vs V419 Lot B: GMC Ratio (Lot A/Lot B): 0.91 (95% CI 0.77 to 1.08)
V419 Lot A vs V419 Lot C: GMC Ratio (Lot A/Lot C): 0.86 (95% CI 0.72 to 1.02)
V419 Lot B vs V419 Lot C: GMC Ratio (Lot B/Lot C): 0.94 (95% CI 0.79 to 1.12)

Population analysed: The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant 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: Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen

Time frame: Postdose 3 (Month 7). Geometric mean (95% Confidence Interval). Unit: mIU/mL

Measure	V419 Lot A n = 588	V419 Lot B n = 599	V419 Lot C n = 580	Control n = 286
Value	1195.96 (1081.62 to 1322.39)	1376.86 (1264.74 to 1498.92)	1414.52 (1297.52 to 1542.06)	609.08 (515.29 to 719.93)

V419 Lot A vs V419 Lot B: GMC Ratio (Lot A/Lot B): 0.87 (95% CI 0.76 to 0.98)
V419 Lot A vs V419 Lot C: GMC Ratio (Lot A/Lot C): 0.85 (95% CI 0.74 to 0.96)
V419 Lot B vs V419 Lot C: GMC Ratio (Lot B/Lot C): 0.98 (95% CI 0.86 to 1.11)

Primary outcome: Geometric Mean Concentration of Antibodies to Diphtheria Toxin

Time frame: Postdose 3 (Month 7). Geometric mean (95% Confidence Interval). Unit: IU/mL

Measure	V419 Lot A n = 622	V419 Lot B n = 625	V419 Lot C n = 618	Control n = 301
Value	0.37 (0.34 to 0.40)	0.36 (0.33 to 0.40)	0.38 (0.34 to 0.41)	0.40 (0.35 to 0.45)

V419 Lot A vs V419 Lot B: GMC Ratio (Lot A/Lot B): 0.95 (95% CI 0.84 to 1.07)
V419 Lot A vs V419 Lot C: GMC Ratio (Lot A/Lot C): 0.97 (95% CI 0.86 to 1.09)
V419 Lot B vs V419 Lot C: GMC Ratio (Lot B/Lot C): 1.02 (95% CI 0.90 to 1.14)

Primary outcome: Geometric Mean Concentration of Antibodies to Tetanus Toxin

Time frame: Postdose 3 (Month 7). Geometric mean (95% Confidence Interval). Unit: IU/mL

Measure	V419 Lot A n = 622	V419 Lot B n = 609	V419 Lot C n = 612	Control n = 300
Value	1.59 (1.51 to 1.67)	1.63 (1.55 to 1.71)	1.55 (1.48 to 1.63)	0.89 (0.81 to 0.97)

V419 Lot A vs V419 Lot B: GMC Ratio (Lot A/Lot B): 0.97 (95% CI 0.91 to 1.04)
V419 Lot A vs V419 Lot C: GMC Ratio (Lot A/Lot C): 1.02 (95% CI 0.95 to 1.09)
V419 Lot B vs V419 Lot C: GMC Ratio (Lot B/Lot C): 1.05 (95% CI 0.98 to 1.13)

22 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 Lots A, B, and C Combined	94 of 2,390 (3.9%)	2,259 of 2,390 (94.5%)	Not reported
Control	15 of 397 (3.8%)	371 of 397 (93.5%)	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.
Results publication: PubMed 27846058Block SL, Klein NP, Sarpong K, Russell S, Fling J, Petrecz M, Flores S, Xu J, Liu G, Stek JE, Foglia G, Lee AW. Lot-to-lot Consistency, Safety, Tolerability and Immunogenicity of an Investigational Hexavalent Vaccine in US Infants. Pediatr Infect Dis J. 2017 Feb;36(2):202-208. doi: 10.1097/INF.0000000000001405.
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, PENTACEL™ and Prevnar 13™ 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 2 May 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?

Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen (time frame: Postdose 3 (Month 7)). The study lists 11 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 NCT01340937, 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.