Bacterial InfectionsPhase 3NCT01341639

Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4 and 12 Months (V419-007)

A Phase 3 study testing V419, INFANRIX™ hexa and RotaTeq in people with Bacterial Infections and Virus Diseases, run by MCM Vaccines B.V..

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 participants who receive the vaccine 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 participants who receive a licensed vaccine control. Read more about this study

Who is it for?: Ages 46 to 74 daysHealthy volunteers can take part
Conditions the study is for: Bacterial Infections, Virus Diseases
What is being tested?: V419, INFANRIX™ hexa and RotaTeq
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: 1,250 participants
Where: No sites listed yet
Study dates: 26 May 2011to 13 Mar 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 74 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy infants able to attend all study visits
Parent(s)/legal representative able to read, understand, and complete study questionnaires

Who cannot join

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

Show all 14Show fewer

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

About this study

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)

Conditions: Bacterial Infections, Virus Diseases
Being tested: V419, INFANRIX™ hexa, RotaTeq, Prevenar 13, ProQuad™
Keywords: combination vaccine, diphtheria, pertussis, tetanus, hepatitis B, Hep B, Haemophilus influenzae b, Hib, polio, poliovirus
Medical subject headings: Bacterial Infections, Virus Diseases, Diphtheria, Whooping Cough, Tetanus, Hepatitis B, Haemophilus Infections, Poliomyelitis

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, 3, 4, and 12 months of age.
INFANRIX™ hexaBiological
INFANRIX™ hexa 0.5 mL intramuscular injection at 2, 3, 4, and 12 months of age.
RotaTeqBiological
RotaTeq (pentavalent combination live vaccine of 5 human-bovine reassortant rotavirus strains) 2 mL oral dose at 2, 3, and 4 months of age
Prevenar 13Biological
Prevenar 13 0.5 mL intramuscular injection at 2, 3, 4,and 13 months of age
ProQuad™Biological
ProQuad™ 0.5 mL subcutaneous injection at 12 and 13 months of age

Study groups in NCT01341639
Study group	Role	What they receive
PR5I	Experimental	V419 + RotaTeq + Prevenar 13 + ProQuad Receives: Biological: V419; Biological: RotaTeq; Biological: Prevenar 13; Biological: ProQuad™
INFANRIX™ hexa	Active comparator	INFANRIX™ hexa + RotaTeq + Prevenar 13 + ProQuad Receives: Biological: INFANRIX™ hexa; Biological: RotaTeq; Biological: Prevenar 13; Biological: ProQuad™

What is being measured

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

Percentage of Participants Vaccinated With PR5I With Acceptable Antibody (Ab) Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months
Antibody titres in the PR5I group were measured by Radioimmunoassay (RIA) for Haemophilus influenzae type b (PRP), Micrometabolic inhibition test (MIT) for diphtheria \& poliovirus, and Enzyme-Linked Immunosorbent Assay (ELISA) for tetanus. Percentage of participants with an Ab titre ≥0.15 μg/mL for Haemophilus influenzae type b (Hib) (polyribosylribitol phosphate, PRP); ≥0.01 IU/mL; for diphtheria \& tetanus; ≥8 (1/dil) for inactivated poliovirus types 1, 2 \& 3 (IPV1, 2 \& 3) are reported. 95% confidence interval (CI) were calculated based on the exact binomial method by Clopper and Pearson. The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than the predetermined lower CI limits for PRP, diphtheria (80%), tetanus (90%), and IPV1, 2 \& 3 (90%).
Measured: One month after post-dose 3 of PRI5 (5 months old)
Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months
Antibody titres in the PR5I group were measured by RIA for PRP, MIT for diphtheria \& poliovirus, enhanced Chemiluminescence assay (ECi)) for Hepatitis B surface antigen (HBsAg) and ELISA for tetanus, Pertussis toxoid (PT), Filamentous haemagglutinin (FHA), Fimbriae types 2 \& 3 (FIM) \& Pertactin (PRN). Percentage of participants with an Ab titre ≥1.0 μg/mL for Hib (PRP); ≥0.1 IU/mL; for diphtheria \& tetanus; ≥10 mIU/mL HBsAg; ≥8 (1/dil) for IPV1, 2 \& 3, and seroresponse to PT, FHA, FIM and PRN are reported. 95% confidence interval (CI) were calculated based on the exact binomial method by Clopper and Pearson. The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than the lower CI limits for PRP, PT, FHA, FIM, and PRN (75%); Diphtheria (80%); HBsAG, IPV 1, 2, 3 (90%).
Measured: One month after Toddler dose of PRI5 (13 months old)
Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months
Antibody titres were measured by RIA for PRP, MIT for diphtheria \& poliovirus, and ELISA for tetanus. Percentage of participants with an Ab titre ≥0.15 μg/mL for Hib) (PRP); ≥0.01 IU/mL; for diphtheria \& tetanus; ≥8 (1/dil) for inactivated poliovirus types 1, 2 \& 3 (IPV1, 2 \& 3) are reported. The estimated response rates are based on the method by Miettinen and Nurminen stratified by country.
Measured: One month after post-dose 3 of PRI5 (5 months old)
Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response Rates to Hepatitis B and Seroresponse to Pertussis Antigens Pt, FHA and PRN One Month After the Toddler Dose at 13 Months Old
Antibody titres were measured by ECi for HBsAg and ELISA for PT, FHA, \& PRN. Percentage of participants with an Ab titre ≥10 mIU/mL HBsAg; ≥8 (1/dil) for IPV1, 2 \& 3, and seroresponse to PT, FHA, and PRN are reported. The estimated response rates are based on the method by Miettinen and Nurminen stratified by country.
Measured: One month after Toddler dose of PRI5 (13 months old)

Secondary outcomes (6)

Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old
Ab titres were measured by ELISA, excepting the Ab to varicella which was determined by glycoprotein ELISA. Percentage of participants with an Ab titre ≥255 mIU/mL for measles, ≥10 Ab units/mL for mumps, ≥10 IU/mL for rubella, and ≥5 gpELISA units/mL for varicella are reported. 95% CI were calculated based on the exact binomial method by Clopper and Pearson. The immune response to ProQuad vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than the predetermined lower CI limits: 90% for measles, mumps \& rubella, and 76% for varicella.
Measured: One month after Toddler dose of PRI5 (13 months old)
Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old
Ab titres were measured by ELISA, excepting the Ab to varicella which was determined by glycoprotein ELISA. Percentage of participants with an Ab titre ≥255 mIU/mL for measles, ≥10 Ab units/mL for mumps, ≥10 IU/mL for rubella, and ≥5 gpELISA units/mL for varicella are reported. The estimated response rates are based on the method by Miettinen and Nurminen stratified by country.
Measured: One month after Toddler dose of PRI5 (13 months old)
Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination
Global safety was assessed by measuring injection-site and systemic AEs reported daily on the Vaccination Report Card (VRC) by the parent(s) or legal representative from Day 1 to Day 15 (D1-D15) after each hexavalent vaccination. Solicited injection-site and systemic AEs were reported daily from Day 1 to Day 5 (D1-D5) after each hexavalent vaccination. AEs at injection sites were always considered as vaccine-related (Injection-Site Reactions (ISRs)). The investigator assessed whether systemic AEs were related (V-related) or not to the vaccine. All AEs (related and unrelated) are reported.
Measured: Day 1 to Day 15 after any vaccination
Percentage of Participants Reporting Solicited ISRs From Day 1 to Day 5 After Any Vaccination
Solicited ISRs were defined as injection-site erythema, injection-site pain, and injection-site swelling occurring from Day 1 (D1) to Day 5 (D5) after vaccination. AEs at injection sites were always considered as vaccine-related (Injection-Site Reactions (ISRs)).
Measured: Day 1 to Day 5 after any vaccination
Percentage of Participants Reporting Unsolicited ISRs From Day 1 to Day 15 After Any Vaccination
Unsolicited ISRs with incidence ≥1% after any vaccination were reported daily on the VRC by the parent(s) or legal representative from (D1-D15). AEs at injection sites were always considered as vaccine-related ISRs
Measured: Day 1 to Day 15 after any vaccination
Percentage of Participants Reporting Solicited Systemic AE From Day 1 to Day 5 After Any Vaccination
Solicited systemic AEs were defined as crying, decreased appetite, irritability, pyrexia (rectal temperature ≥38.0°C), somnolence, and vomiting occurring from D1 to D5 after vaccination. The investigator assessed whether these systemic AEs were related or not to the vaccines. All (related and unrelated) AEs are reported.
Measured: Day 1 to Day 5 after any vaccination

Timeline

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

26 May 201113 Mar 2013

First posted26 Apr 2011 (estimated)
Study start26 May 2011
Primary completion13 Mar 2013
Study completion13 Mar 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.
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: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,250 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01341639
Sponsor's protocol ID: V419-007
Other IDs: 2010-021490-37
Status last verified: Apr 2019
First submitted: 22 Apr 2011
Last updated: 30 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

Vesikari T, Becker T, Vertruyen AF, Poschet K, Flores SA, Pagnoni MF, Xu J, Liu GF, Stek JE, Boisnard F, Thomas S, Ziani E, Lee AW. A Phase III Randomized, Double-blind, Clinical Trial of an Investigational Hexavalent Vaccine Given at Two, Three, Four and Twelve Months. Pediatr Infect Dis J. 2017 Feb;36(2):209-215. doi: 10.1097/INF.0000000000001406.
PubMed 27846055

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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All Bacterial Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT01341639
Acronym / sponsor ID: V419-007
Conditions: Bacterial Infections, Virus Diseases
Keywords: combination vaccine, diphtheria, pertussis, tetanus, hepatitis B, Hep B, Haemophilus influenzae b, Hib
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,250 participants (actual)
Lead sponsor: MCM Vaccines B.V.Industry (pharma, biotech, devices)
Collaborators: Merck Sharp & Dohme LLC
Study start: 26 May 2011 (actual)
Primary completion: 13 Mar 2013 (actual)
Study completion: 13 Mar 2013 (actual)
First posted: 26 Apr 2011 (estimated)
Results: Posted 10 Apr 2019

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: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
PR5I	Experimental	Biological: V419, Biological: RotaTeq, Biological: Prevenar 13, Biological: ProQuad™V419 + RotaTeq + Prevenar 13 + ProQuad
INFANRIX™ hexa	Active comparator	Biological: INFANRIX™ hexa, Biological: RotaTeq, Biological: Prevenar 13, Biological: ProQuad™INFANRIX™ hexa + RotaTeq + Prevenar 13 + ProQuad

Who may qualify

Ages: 46 to 74 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (2 listed)

Healthy infants able to attend all study visits
Parent(s)/legal representative able to read, understand, and complete study questionnaires

Key exclusion criteria (14 listed)

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

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, 3, 4, and 12 months of age.	Biological	PR5I
INFANRIX™ hexaINFANRIX™ hexa 0.5 mL intramuscular injection at 2, 3, 4, and 12 months of age.	Biological	INFANRIX™ hexa
RotaTeqRotaTeq (pentavalent combination live vaccine of 5 human-bovine reassortant rotavirus strains) 2 mL oral dose at 2, 3, and 4 months of age	Biological	INFANRIX™ hexa, PR5I
Prevenar 13Prevenar 13 0.5 mL intramuscular injection at 2, 3, 4,and 13 months of age	Biological	INFANRIX™ hexa, PR5I
ProQuad™ProQuad™ 0.5 mL subcutaneous injection at 12 and 13 months of age	Biological	INFANRIX™ hexa, PR5I

Primary outcome

Percentage of Participants Vaccinated With PR5I With Acceptable Antibody (Ab) Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months
Time frame: One month after post-dose 3 of PRI5 (5 months old)
Antibody titres in the PR5I group were measured by Radioimmunoassay (RIA) for Haemophilus influenzae type b (PRP), Micrometabolic inhibition test (MIT) for diphtheria \& poliovirus, and Enzyme-Linked Immunosorbent Assay (ELISA) for tetanus. Percentage of participants with an Ab titre ≥0.15 μg/mL for Haemophilus influenzae type b (Hib) (polyribosylribitol phosphate, PRP); ≥0.01 IU/mL; for diphtheria \& tetanus; ≥8 (1/dil) for inactivated poliovirus types 1, 2 \& 3 (IPV1, 2 \& 3) are reported. 95% confidence interval (CI) were calculated based on the exact binomial method by Clopper and Pearson. The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than the predetermined lower CI limits for PRP, diphtheria (80%), tetanus (90%), and IPV1, 2 \& 3 (90%).
Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months
Time frame: One month after Toddler dose of PRI5 (13 months old)
Antibody titres in the PR5I group were measured by RIA for PRP, MIT for diphtheria \& poliovirus, enhanced Chemiluminescence assay (ECi)) for Hepatitis B surface antigen (HBsAg) and ELISA for tetanus, Pertussis toxoid (PT), Filamentous haemagglutinin (FHA), Fimbriae types 2 \& 3 (FIM) \& Pertactin (PRN). Percentage of participants with an Ab titre ≥1.0 μg/mL for Hib (PRP); ≥0.1 IU/mL; for diphtheria \& tetanus; ≥10 mIU/mL HBsAg; ≥8 (1/dil) for IPV1, 2 \& 3, and seroresponse to PT, FHA, FIM and PRN are reported. 95% confidence interval (CI) were calculated based on the exact binomial method by Clopper and Pearson. The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than the lower CI limits for PRP, PT, FHA, FIM, and PRN (75%); Diphtheria (80%); HBsAG, IPV 1, 2, 3 (90%).
Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months
Time frame: One month after post-dose 3 of PRI5 (5 months old)
Antibody titres were measured by RIA for PRP, MIT for diphtheria \& poliovirus, and ELISA for tetanus. Percentage of participants with an Ab titre ≥0.15 μg/mL for Hib) (PRP); ≥0.01 IU/mL; for diphtheria \& tetanus; ≥8 (1/dil) for inactivated poliovirus types 1, 2 \& 3 (IPV1, 2 \& 3) are reported. The estimated response rates are based on the method by Miettinen and Nurminen stratified by country.
Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response Rates to Hepatitis B and Seroresponse to Pertussis Antigens Pt, FHA and PRN One Month After the Toddler Dose at 13 Months Old
Time frame: One month after Toddler dose of PRI5 (13 months old)
Antibody titres were measured by ECi for HBsAg and ELISA for PT, FHA, \& PRN. Percentage of participants with an Ab titre ≥10 mIU/mL HBsAg; ≥8 (1/dil) for IPV1, 2 \& 3, and seroresponse to PT, FHA, and PRN are reported. The estimated response rates are based on the method by Miettinen and Nurminen stratified by country.

6 secondary outcomes

Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old
Time frame: One month after Toddler dose of PRI5 (13 months old)
Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old
Time frame: One month after Toddler dose of PRI5 (13 months old)
Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination
Time frame: Day 1 to Day 15 after any vaccination
Percentage of Participants Reporting Solicited ISRs From Day 1 to Day 5 After Any Vaccination
Time frame: Day 1 to Day 5 after any vaccination
Percentage of Participants Reporting Unsolicited ISRs From Day 1 to Day 15 After Any Vaccination
Time frame: Day 1 to Day 15 after any vaccination
Percentage of Participants Reporting Solicited Systemic AE From Day 1 to Day 5 After Any Vaccination
Time frame: Day 1 to Day 5 after any vaccination

Results and safety

Results posted to the registry on 10 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PR5I	628	599
INFANRIX™ Hexa	622	590

Primary outcome: Percentage of Participants Vaccinated With PR5I With Acceptable Antibody (Ab) Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months

Time frame: One month after post-dose 3 of PRI5 (5 months old). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	PR5I n = 550
Anti-PRP ≥0.15 μg/mL	98.36 (96.92 to 99.25)
Anti-Diphtheria ≥0.01 IU/mL	99.82 (98.98 to 100)
Anti-Tetanus ≥0.01 IU/mL	100 (99.32 to 100)
Anti-IPV1 ≥8 (1/dil)	100 (99.33 to 100)
Anti-IPV2 ≥8 (1/dil)	99.82 (98.99 to 100)
Anti-IPV3 ≥8 (1/dil)	100 (99.33 to 100)

Population analysed: All participants in the PR5I group who met inclusion criteria, were not protocol violators, received vaccinations within acceptable day ranges, and who had serology results within revised windows (RW) of Days 28 to 51 Post-Dose 3. Participants from site 0048 were excluded. Participants in the INFANRIX™ hexa group were not analyzed.

Primary outcome: Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months

Time frame: One month after Toddler dose of PRI5 (13 months old). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	PR5I n = 551
Anti-PRP ≥1.0 μg/mL	94.99 (92.51 to 96.83)
Anti-Diphtheria ≥0.1 IU/mL	99.81 (98.96 to 100)
Anti-Tetanus ≥0.1 IU/mL	100 (99.3 to 100)
Anti-IPV1 ≥8 (1/dil)	99.81 (98.97 to 100)
Anti-IPV2 ≥8 (1/dil)	100 (99.32 to 100)
Anti-IPV3 ≥8 (1/dil)	100 (99.32 to 100)
Anti-HBsAg ≥10 mIU/mL	99.64 (98.7 to 99.96)
Anti-PT seroresponse	99.82 (98.98 to 100)

Population analysed: All participants in the PR5I group who met inclusion criteria, were not protocol violators, received vaccinations within acceptable day ranges, and who had serology results within RW of Days 28 to 51 Post-Toddler dose. Participants from site 0048 were excluded. Participants in the INFANRIX™ hexa group were not analyzed for this outcome measure.

Primary outcome: Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months

Time frame: One month after post-dose 3 of PRI5 (5 months old). Number. Unit: Percentage of participants

Measure	PR5I n = 550	INFANRIX™ Hexa n = 530
Anti-PRP ≥0.15 μg/mL	98.36	86.99
Anti-Diphtheria ≥0.01 IU/mL	99.81	99.81
Anti-Tetanus ≥0.01 IU/mL	100	100
Anti-IPV1 ≥8 (1/dil)	100	99.81
Anti-IPV2 ≥8 (1/dil)	99.82	99.62
Anti-IPV3 ≥8 (1/dil)	100	100

PR5I vs INFANRIX™ Hexa: Difference in percentages: 11.37 (95% CI 8.44 to 14.68), p < 0.001, Miettinen & Nurminen
PR5I vs INFANRIX™ Hexa: Difference in percentages: 0 (95% CI -0.95 to 0.96), p < 0.001, Miettinen & Nurminen
PR5I vs INFANRIX™ Hexa: Difference in percentages: 0 (95% CI -0.71 to 0.74), p < 0.001, Miettinen & Nurminen

Population analysed: All participants who met inclusion criteria, were not protocol violators, received vaccinations within acceptable day ranges, and who had serology results within RW of Days 28 to 51 Post-Dose 3. Participants from site 0048 were excluded.

Primary outcome: Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response Rates to Hepatitis B and Seroresponse to Pertussis Antigens Pt, FHA and PRN One Month After the Toddler Dose at 13 Months Old

Time frame: One month after Toddler dose of PRI5 (13 months old). Number. Unit: Percentage of participants

Measure	PR5I n = 551	INFANRIX™ Hexa n = 531
Anti-HBsAg ≥10 mIU/mL	99.64	99.06
Anti-PT seroresponse	99.82	98.49
Anti-FHA seroresponse	97.22	99.81
Anti-PRN seroresponse	98.89	98.86

PR5I vs INFANRIX™ Hexa: Difference in percentages: 0.58 (95% CI -0.49 to 1.85), p < 0.001, Miettinen & Nurminen
PR5I vs INFANRIX™ Hexa: Difference in percentages: 1.33 (95% CI 0.32 to 2.86), p < 0.001, Miettinen & Nurminen
PR5I vs INFANRIX™ Hexa: Difference in percentages: -2.59 (95% CI -4.39 to -1.29), p < 0.001, Miettinen & Nurminen

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 months after Toddler Dose (up to approximately age 14 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PR5I	23 of 610 (3.8%)	603 of 610 (98.9%)	0 of 610
INFANRIX Hexa	22 of 605 (3.6%)	599 of 605 (99%)	0 of 605

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27846055Vesikari T, Becker T, Vertruyen AF, Poschet K, Flores SA, Pagnoni MF, Xu J, Liu GF, Stek JE, Boisnard F, Thomas S, Ziani E, Lee AW. A Phase III Randomized, Double-blind, Clinical Trial of an Investigational Hexavalent Vaccine Given at Two, Three, Four and Twelve Months. Pediatr Infect Dis J. 2017 Feb;36(2):209-215. doi: 10.1097/INF.0000000000001406.
Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/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, INFANRIX™ hexa and RotaTeq in people with Bacterial Infections and Virus Diseases, run by MCM Vaccines B.V..

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 14 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 30 Apr 2019. 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 10 Apr 2019). 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 Vaccinated With PR5I With Acceptable Antibody (Ab) Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months (time frame: One month after post-dose 3 of PRI5 (5 months old)). The study lists 4 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 NCT01341639, 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 30 Apr 2019.