Trial · NCT01340937

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

NCT01340937, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2016-05-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006). Trials, record NCT01340937. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01340937

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-006)
NCT number: NCT01340937
Status: Completed
Phases: Phase 3
Enrollment: 2,808 participants, actual
Lead sponsor: Merck Sharp & Dohme LLC
Conditions: Bacterial Infections, Virus Diseases
Interventions: V419, PENTACEL™, Prevnar 13™, RotaTeq™, Recombivax HB vaccine
First posted: 2011-04-25
Last updated: 2018-11-15
Results first posted: 2016-05-02

Source ClinicalTrials.gov

Registered outcomes33

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen	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.
Primary	Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen	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).
Primary	Geometric Mean Concentration of Antibodies to Diphtheria Toxin	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).
Primary	Geometric Mean Concentration of Antibodies to Tetanus Toxin	Postdose 3 (Month 7)	Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for anti-tetanus antibodies.
Primary	Geometric Mean Concentration of Antibodies to Pertussis Toxin	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).
Primary	Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin	Postdose 3 (Month 7)	Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin.
Primary	Geometric Mean Concentration of Antibodies to Pertussis Pertactin	Postdose 3 (Month 7)	Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.
Primary	Geometric Mean Concentration of Antibodies to Pertussis Fimbriae	Postdose 3 (Month 7)	Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.
Primary	Geometric Mean Titer for Antibodies to Poliovirus Type 1	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).
Primary	Geometric Mean Titer for Antibodies to Poliovirus Type 2	Postdose 3 (Month 7)	Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2.

1 to 10 of 33Source ClinicalTrials.gov

See all 33 registered outcomes

Outcomes33

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen	Postdose 3 (Month 7)	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.	µg/mL	GEOMETRIC_MEAN
SECONDARY	Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen	Postdose 3 (Month 7)	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.	Percentage of participants	NUMBER
PRIMARY	Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen	Postdose 3 (Month 7)	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.	mIU/mL	GEOMETRIC_MEAN
PRIMARY	Geometric Mean Concentration of Antibodies to Diphtheria Toxin	Postdose 3 (Month 7)	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.	IU/mL	GEOMETRIC_MEAN
PRIMARY	Geometric Mean Concentration of Antibodies to Tetanus Toxin	Postdose 3 (Month 7)	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.	IU/mL	GEOMETRIC_MEAN
PRIMARY	Geometric Mean Concentration of Antibodies to Pertussis Toxin	Postdose 3 (Month 7)	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.	EU/mL	GEOMETRIC_MEAN
PRIMARY	Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin	Postdose 3 (Month 7)	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.	EU/mL	GEOMETRIC_MEAN
PRIMARY	Geometric Mean Concentration of Antibodies to Pertussis Pertactin	Postdose 3 (Month 7)	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.	EU/mL	GEOMETRIC_MEAN
PRIMARY	Geometric Mean Concentration of Antibodies to Pertussis Fimbriae	Postdose 3 (Month 7)	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.	EU/mL	GEOMETRIC_MEAN
PRIMARY	Geometric Mean Titer for Antibodies to Poliovirus Type 1	Postdose 3 (Month 7)	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.	Titer	GEOMETRIC_MEAN

1 to 10 of 33Source ClinicalTrials.gov

See all 33 outcomes

Results by group266

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen	V419 Lot A		5.51	95% Confidence Interval 4.88 to 6.21	µg/mL
Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen	V419 Lot B		6.10	95% Confidence Interval 5.38 to 6.92	µg/mL
Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen	V419 Lot C		6.59	95% Confidence Interval 5.80 to 7.47	µg/mL
Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen	Control		3.76	95% Confidence Interval 3.11 to 4.55	µg/mL
Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen	V419 Lots A, B, and C Combined		6.05	95% Confidence Interval 5.63 to 6.50	µg/mL
Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen	V419 Lot A	Titer >=1 µg/mL	86.75	95% Confidence Interval 83.79 to 89.36	Percentage of participants
Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen	V419 Lot B	Titer >=1 µg/mL	87.25	95% Confidence Interval 84.30 to 89.82	Percentage of participants
Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen	V419 Lot C	Titer >=1 µg/mL	88.40	95% Confidence Interval 85.55 to 90.86	Percentage of participants
Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen	Control	Titer >=1 µg/mL	79.51	95% Confidence Interval 74.39 to 84.02	Percentage of participants
Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen	V419 Lots A, B, and C Combined	Titer >=1 µg/mL	87.47	95% Confidence Interval 85.84 to 88.96	Percentage of participants

1 to 10 of 266Source ClinicalTrials.gov

See all 266 results by group

Participant flow36

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Period 1: Infant Series	STARTED	V419 Lot A	800
Period 1: Infant Series	STARTED	V419 Lot B	797
Period 1: Infant Series	STARTED	V419 Lot C	809
Period 1: Infant Series	STARTED	Control	402
Period 1: Infant Series	COMPLETED	V419 Lot A	742
Period 1: Infant Series	COMPLETED	V419 Lot B	737
Period 1: Infant Series	COMPLETED	V419 Lot C	753
Period 1: Infant Series	COMPLETED	Control	370
Period 1: Infant Series	NOT COMPLETED	V419 Lot A	58
Period 1: Infant Series	NOT COMPLETED	V419 Lot B	60

1 to 10 of 36Source ClinicalTrials.gov

See all 36 participant flow

Adverse events174

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhoea	Gastrointestinal disorders	V419 Lots A, B, and C Combined	192	2,390	215
other	Diarrhoea	Gastrointestinal disorders	Control	23	397	24
other	Vomiting	Gastrointestinal disorders	V419 Lots A, B, and C Combined	723	2,390	1,139
other	Vomiting	Gastrointestinal disorders	Control	110	397	171
other	Crying	General disorders	V419 Lots A, B, and C Combined	1,867	2,390	4,597
other	Crying	General disorders	Control	300	397	763
other	Irritability	General disorders	V419 Lots A, B, and C Combined	1,993	2,390	5,595
other	Irritability	General disorders	Control	324	397	925
other	Pyrexia	General disorders	V419 Lots A, B, and C Combined	1,285	2,390	2,302
other	Pyrexia	General disorders	Control	174	397	274

1 to 10 of 174Source ClinicalTrials.gov

See all 174 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	V419 Lots A, B, and C Combined
Total, all-cause mortality	Control
Total, other adverse events	V419 Lots A, B, and C Combined	2,259	2,390
Total, other adverse events	Control	371	397
Total, serious adverse events	V419 Lots A, B, and C Combined	94	2,390
Total, serious adverse events	Control	15	397

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
27846058	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
V419 Lots A, B, and C Combined vs Control: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01340937

GET https://conductscience.org/api/trials/v1/NCT01340937/registered?page=2

API reference For AI assistants