NCT02914184 is a Phase 3 clinical trial of HRV PCV-free liquid vaccine in Infections, Rotavirus, sponsored by GlaxoSmithKline.

Who is sponsoring NCT02914184?

NCT02914184 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT02914184?

Interventions in NCT02914184: HRV PCV-free liquid vaccine, Rotarix.

What condition does NCT02914184 study?

NCT02914184 studies Infections, Rotavirus, Rotavirus Vaccines.

Is NCT02914184 still recruiting?

NCT02914184 is currently completed. Last updated 21 July 2020.

Are results published for NCT02914184?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-07-21 · How we verify

NCT02914184

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Evaluation of Immunogenicity and Safety of Two Formulations of GSK Biologicals' Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks

Completed Phase 3 Results posted Last updated 21 July 2020

What this trial tests

Phase 3 trial testing HRV PCV-free liquid vaccine in Infections, Rotavirus in 1,612 participants. Completed in 26 November 2018.

Timeline

27 October 2016

Primary endpoint
27 June 2018

26 November 2018

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	1,612
Start date	27 October 2016
Primary completion	27 June 2018
Estimated completion	26 November 2018
Sites	66 locations across Finland, Japan, Costa Rica, Taiwan, Germany, South Korea, United States, Spain

Drugs / interventions tested

HRV PCV-free liquid vaccine — full drug profile →
Rotarix — full drug profile →

Conditions studied

Infections, Rotavirus — all drugs for Infections, Rotavirus →
Rotavirus Vaccines — all drugs for Rotavirus Vaccines →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 6 Weeks to 12 Weeks, any sex, with Infections, Rotavirus or Rotavirus Vaccines. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Anti-Rota Virus (Anti-RV) Immunoglobulin A (IgA) Antibody Concentrations in the Human Rotavirus (HRV) Liquid Formulation Groups (Liq_A, Liq_B and Liq_C) Primary · At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)

Antibody concentrations against Rota Virus (RV) were determined as Geometric Mean Antibody Concentration (GMC) and expressed as Units per milliliter (U/mL).

Group	Value	95% CI
Liq_A Group	155.7	125.6 – 193.1
Liq_B Group	147.3	118.4 – 183.3
Liq_C Group	175.9	142.8 – 216.8

Percentage of Seroconverted Subjects With RV Antibody Concentrations Above or Equal to Cut-off Value in Porcine Circovirus (PCV) -Free Liquid HRV Vaccine (Pooled HRV Liquid Group) and Control Group Primary · At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)

Seroconversion rate (SCR) was defined as the percentage of subjects who were initially seronegative (i.e., with anti-RV IgA antibody concentration less than (\<) 20 U/mL before the first dose of HRV vaccine) and developed anti-RV IgA antibody concentration greater than or equal to (≥) 20 U/mL at Month 2-4 (1-2 months after dose 2). SCR was analysed using Enzyme Linked Immunosorbent Assay (ELISA). For this outcome measure, the three groups (Liq\_A, Liq\_B \& Liq\_C) were pooled into a single group (Liq\_Pool group) as they all received PCV free-liquid HRV vaccine, and as pre-specified in the p

Group	Value	95% CI
Liq_Pool Group	79.3	76.6 – 81.8
Lyo Control Group	81.8	77.2 – 85.8

Percentage of Seroconverted Subjects With RV Antibody Concentrations Above or Equal to 20 U/mL in Porcine Circovirus (PCV)-Free Liquid HRV Vaccine (Individual HRV Liquid Groups) and Lyophilised Control Group Primary · At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)

Seroconversion rate (SCR) was defined as the percentage of subjects who were initially seronegative (i.e., with anti-RV IgA antibody concentration less than (\<) 20 U/mL before the first dose of HRV vaccine) and developed anti-RV IgA antibody concentration greater than or equal to (≥) 20 U/mL at Month 2-4 (1-2 months after dose 2). SCR was analysed using Enzyme Linked Immunosorbent Assay (ELISA). The analysis was assessed to demonstrate the immunogenicity of PCV-free liquid HRV vaccine as compared to the currently licensed lyophilised HRV vaccine (individual HRV liquid groups) in terms of ser

Group	Value	95% CI
Liq_A Group	77.7	72.8 – 82.1
Liq_B Group	77.6	72.7 – 82.0
Liq_C Group	82.5	77.9 – 86.5
Lyo Control Group	81.8	77.2 – 85.8

Anti-RV IgA Antibody Concentrations in the PCV-free Liquid HRV Vaccine (Pooled HRV Liquid Group) and Lyophilised Control Group Primary · At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)

Antibody concentrations against RV were determined as GMCs and expressed as U/mL. For this outcome measure, the three groups (Liq\_A, Liq\_B \& Liq\_C) were pooled into a single group (Liq\_Pool group) as they all received PCV free-liquid HRV vaccine, and as pre-specified in the protocol, the immunological non-inferiority of the Liq\_Pool group was compared to the currently licensed lyophilized HRV vaccine (Lyo\_Control group) in terms of antibody concentrations at 1-2 months after Dose 2.

Group	Value	95% CI
Liq_Pool Group	159.2	140.7 – 180.1
Lyo Control Group	153.8	125.1 – 189.0

Anti-RV IgA Antibody Concentrations in the PCV-free Liquid HRV Vaccine (Individual HRV Liquid Groups) and Lyophilised Control Group Primary · At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)

Antibody concentrations against RV were determined as GMCs and expressed as U/mL. The analysis was assessed to demonstrate the immunogenicity of the PCV-free liquid HRV vaccine (individual HRV liquid groups) to that of the currently licensed lyophilised HRV vaccine in terms of serum anti-RV IgA antibody concentrations 1-2 months after Dose 2.

Group	Value	95% CI
Liq_A Group	155.7	125.6 – 193.1
Liq_B Group	147.3	118.4 – 183.3
Liq_C Group	175.9	142.8 – 216.8
Lyo Control Group	153.8	125.1 – 189.0

Percentage of Subjects With Anti-RV IgA Concentrations (Pooled HRV Liquid Group) Secondary · At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)

Antibody concentrations ≥90 U/mL were determined and expressed as GMCs, assessed for the pooled HRV liquid groups and Control Group. The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations. For this outcome measure, the three groups (Liq\_A, Liq\_B \& Liq\_C) were pooled into a single group (Liq\_Pool group) as they all received PCV free-liquid HRV vaccine, and as pre-specified in the protocol, the immunogenicity of the Liq\_Pool group was compared to the currently licensed lyophilized HRV vaccine (Lyo\_Control group) in terms of percent

Group	Value	95% CI
Liq_Pool Group	63.0	59.9 – 66.0
Lyo Control Group	62.3	56.8 – 67.6

Percentage of Subjects With Anti-RV IgA Concentrations (Individual HRV Liquid Groups) Secondary · At Month 2-4 (i.e. approximately 1-month or 2-months after second dose of HRV vaccine according to the immunisation schedule for RV vaccine administration in participating countries)

Antibody concentrations ≥90 U/mL were determined and expressed as GMCs, assessed for the individual HRV liquid groups and Control Group. The GMC calculations were performed by taking the anti-log of the mean of the log concentration transformations. The analysis was performed to assess the immunogenicity of the PCV-free liquid HRV vaccine (pooled HRV liquid groups) and the currently licensed lyophilised HRV vaccine, in terms of percentage of subjects with anti-RV IgA antibody concentrations ≥ 90 U/mL 1-2 months after Dose 2.

Group	Value	95% CI
Liq_A Group	62.7	57.2 – 67.9
Liq_B Group	61.0	55.5 – 66.4
Liq_C Group	65.3	59.9 – 70.5
Lyo Control Group	62.3	56.8 – 67.6

Number of Subjects With Any Solicited General Adverse Events (AEs). Secondary · During the 8 days (Day 1 to Day 8) follow-up period after each dose of HRV vaccine

Assessed solicited general AEs were cough/runny nose, diarrhea, fever (defined as temperature ≥ 38.0°C), irritability/fussiness, loss of appetite and vomiting. Any solicited general AE is defined as any occurrence of the specified symptom, irrespective of intensity grade and relationship to vaccination.

Any - Cough / Runny Nose - Dose 1

Group	Value	95% CI
Liq_A Group	93
Liq_B Group	91
Liq_C Group	94
Lyo Control Group	102

Any - Cough / Runny Nose - Dose 2

Group	Value	95% CI
Liq_A Group	114
Liq_B Group	100
Liq_C Group	94
Lyo Control Group	109

Any - Diarrhea - Dose 1

Group	Value	95% CI
Liq_A Group	14
Liq_B Group	13
Liq_C Group	8
Lyo Control Group	10

Any - Diarrhea - Dose 2

Group	Value	95% CI
Liq_A Group	7
Liq_B Group	12
Liq_C Group	8
Lyo Control Group	11

Any - Fever (≥ 38.0°C) - Dose 1

Group	Value	95% CI
Liq_A Group	24
Liq_B Group	22
Liq_C Group	20
Lyo Control Group	23

Any - Fever (≥ 38.0°C) - Dose 2

Group	Value	95% CI
Liq_A Group	36
Liq_B Group	36
Liq_C Group	34
Lyo Control Group	32

Any - Irritability / Fussiness - Dose 1

Group	Value	95% CI
Liq_A Group	226
Liq_B Group	214
Liq_C Group	209
Lyo Control Group	216

Any - Irritability / Fussiness - Dose 2

Group	Value	95% CI
Liq_A Group	191
Liq_B Group	189
Liq_C Group	194
Lyo Control Group	194

Number of Subjects With Any Unsolicited AEs. Secondary · During the 31 day (Day 1 to Day 31) follow-up period after HRV vaccination across doses

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any is defined as the occurrence of any unsolicited AE irrespective of its intensity grade and relationship to vaccination.

Group	Value	95% CI
Liq_A Group	183
Liq_B Group	189
Liq_C Group	200
Lyo Control Group	184

Number of Subjects With Any Serious Adverse Events (SAEs) Secondary · During the entire study period (Day 1 to Month 7-8)

SAEs assessed include any untoward medical occurrence that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity.

Group	Value	95% CI
Liq_A Group	21
Liq_B Group	18
Liq_C Group	21
Lyo Control Group	18

Adverse events — posted to ClinicalTrials.gov

Time frame: Solicited AEs: During the 8 days (Day 1 to Day 8) follow-up period after each vaccination. Unsolicited AEs: During the 31 days (Day 1 to Day 31) follow-up period after vaccination. SAEs: Throughout the study period (Day 1 to Month 7-8).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Liq_A Group

Serious: 21/400 (5%)

Deaths: 0/400

Liq_B Group

Serious: 18/396 (5%)

Deaths: 0/396

Liq_C Group

Serious: 21/402 (5%)

Deaths: 0/402

Lyo Control Group

Serious: 18/402 (4%)

Deaths: 0/402

Serious adverse events (51 terms)

Reaction	System	Liq_A Group	Liq_B Group	Liq_C Group	Lyo Control Group
Respiratory syncytial virus bronchiolitis	Infections and infestations	—	—	—	—
Bronchiolitis	Infections and infestations	—	—	—	—
Otitis media acute	Infections and infestations	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—
Respiratory syncytial virus infection	Infections and infestations	—	—	—	—
Abscess jaw	Infections and infestations	—	—	—	—
Acute sinusitis	Infections and infestations	—	—	—	—
Allergic gastroenteritis	Gastrointestinal disorders	—	—	—	—
Bronchospasm	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Concussion	Injury, poisoning and procedural complications	—	—	—	—
Conjunctivitis	Infections and infestations	—	—	—	—
Eczema	Skin and subcutaneous tissue disorders	—	—	—	—
Encephalitis enteroviral	Infections and infestations	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—
Gastroenteritis viral	Infections and infestations	—	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—	—
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Infantile colic	Gastrointestinal disorders	—	—	—	—
Infantile spasms	Nervous system disorders	—	—	—	—
Influenza	Infections and infestations	—	—	—	—
Intussusception	Gastrointestinal disorders	—	—	—	—

Other adverse events (175 terms — click to expand)

Reaction	System	Liq_A Group	Liq_B Group	Liq_C Group	Lyo Control Group
Irritability	Psychiatric disorders	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—	—
Conjunctivitis	Infections and infestations	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Bronchiolitis	Infections and infestations	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—
Dermatitis atopic	Skin and subcutaneous tissue disorders	—	—	—	—
Eczema	Skin and subcutaneous tissue disorders	—	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—	—
Oral candidiasis	Infections and infestations	—	—	—	—
Respiratory tract infection	Infections and infestations	—	—	—	—
Dermatitis diaper	Skin and subcutaneous tissue disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—
Influenza	Infections and infestations	—	—	—	—
Vaccination complication	Injury, poisoning and procedural complications	—	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Dermatitis	Skin and subcutaneous tissue disorders	—	—	—	—
Otitis media	Infections and infestations	—	—	—	—
Otitis media acute	Infections and infestations	—	—	—	—
Teething	Gastrointestinal disorders	—	—	—	—
Vaccination site pain	General disorders	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—
Haematochezia	Gastrointestinal disorders	—	—	—	—
Regurgitation	Gastrointestinal disorders	—	—	—	—
Pain	General disorders	—	—	—	—
Candida infection	Infections and infestations	—	—	—	—
Ear infection	Infections and infestations	—	—	—	—
Impetigo	Infections and infestations	—	—	—	—
Oral fungal infection	Infections and infestations	—	—	—	—

Most-reported serious reactions: Respiratory syncytial virus bronchiolitis, Bronchiolitis, Otitis media acute, Urinary tract infection, Bronchitis, Dehydration, Respiratory syncytial virus infection, Abscess jaw.

Data from ClinicalTrials.gov NCT02914184 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the clinical consistency of three production lots of the Porcine circovirus (PCV)-free liquid formulation of oral live attenuated human rotavirus (HRV) vaccine and to evaluate the PCV-free liquid formulation of HRV vaccine as compared to the currently licensed lyophilised formulation of the HRV vaccine in terms of immunogenicity, reactogenicity and safety when administered as a two-dose vaccination in healthy infants starting at age 6-12 weeks. No new subjects will be enrolled in the extension phase of the study.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Immunogenicity and safety of porcine circovirus-free human rotavirus vaccine in healthy infants: a phase III, randomized trial.
Salamanca de la Cueva I, Pahud B, Huang LM, Leonardi M, et al · · 2020 · cited 1× · PMID 32365189 · DOI 10.1093/infdis/jiaa210

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02914184 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 21 July 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02914184.

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