A Phase 3 interventional study of RotaTeq (V260) and IPV in Prevention of Rotavirus Gastroenteritis in Infants and Children Caused by Serotypes G1, G2, G3, G4, and G9, sponsored by Merck Sharp & Dohme LLC. Completed at 1 site in China. Open to participants aged 48 Days to 63 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-26.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 3, Interventional, and Prevention
This study will evaluate the immunogenicity and safety of concomitant administration of RotaTeq® (V260) and inactivated poliomyelitis vaccine (IPV) in Chinese infants. Its primary objective is to demonstrate that the immunogenicity of IPV in the concomitant-use group is non-inferior to the immunogenicity of IPV in the staggered-use group. The hypothesis to be tested is: The seroconversion percentage at 1 month post dose 3 for poliovirus types 1, 2, and 3 in the concomitant-use group is non-inferior to those of the staggered-use group.
237 studies on the registry are indexed under Gastroenteritis; 16 are open to participants now.
This study's enrollment of 400 is above the median of 136 across 164 interventional studies indexed under Gastroenteritis.
Browse Gastroenteritis studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 132 are open to participants now.
Of its 501 completed or terminated interventional studies of FDA-regulated products, 370 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive RotaTeq (2 mL oral dose) and IPV (0.5 mL intramuscular \[IM\] injection ) concomitantly at Visit 2 (15 to 21 days after Visit 1 \[Day 1\]), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).
Biological: RotaTeq (V260) · Biological: IPV
Participants will receive RotaTeq (2 mL oral dose) at Visit 1 (Day 1), Visit 3 (30 to 42 days after Visit 1), and Visit 5 (30 to 42 days after Visit 3); and IPV (0.5 mL IM injection) at Visit 2 (15 to 21 days Visit 1), Visit 4 (30 to 42 days after Visit 2), and Visit 6 (30 to 42 days after Visit 4).
Biological: RotaTeq (V260) · Biological: IPV
Live, pentavalent rotavirus vaccine administered as a 2 mL-dose oral solution
Also known as: RotaTeq, V260
0.5 mL dose IPV (Sabin strain based), administered via IM injection
Percentage of Participants Achieving Neutralizing Antibody Seroconversion to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV
The immunogenicity of IPV was measured using poliovirus serum neutralizing antibody assay of the National Institutes for Food and Drug Control (NIFDC), Beijing, China. Serum conversion was defined as antibody titer ≥1:8 post-vaccination in baseline seronegative participants or ≥4-fold increase in titer post-vaccination in baseline seropositive participants.
Time frame: Baseline and 1 month postdose 3 of IPV (Month ~3.5)
Geometric Mean Titers (GMTs) of Neutralizing Antibody to Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV
The immune response to IPV was measured using poliovirus serum neutralizing antibody assay of the NIFDC, Beijing, China.
Time frame: 1 month postdose 3 of IPV (Month ~3.5)
Percentage of Participants Achieving Neutralizing Antibody Titers ≥1:8 for Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV
The immune response to IPV was measured using poliovirus serum neutralizing antibody assay of the NIFDC, Beijing, China.
Time frame: 1 month post dose 3 of IPV (Month ~3.5)
Percentage of Participants Achieving Neutralizing Antibody Titers ≥1:64 for Poliovirus Types 1, 2, and 3 at 1 Month Post Dose 3 of IPV
The immune response to IPV was measured using poliovirus serum neutralizing antibody assay of the NIFDC, Beijing, China.
Time frame: 1 month postdose 3 of IPV (Month ~3.5)
Percentage of Participants With Solicited Injection-Site Adverse Events
Solicited injection-site adverse events (AEs) included erythema, swelling, induration, and pain at the IPV injection-site.
Time frame: Up to 7 days following each IPV vaccination
Percentage of Participants With Solicited Systemic Adverse Events
Solicited systemic AEs included diarrhea, vomiting, and elevated temperature (axillary temperature ≥37.5º C).
Time frame: Up to 7 days following each RotaTeq and/or IPV vaccination
Percentage of Participants With Serious Adverse Events (SAEs)
The percentage of participants with SAEs is presented. An SAE is an AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or another important medical event.
Time frame: Up to approximately 3.5 months
| Milestone | Concomitant RotaTeq and IPV | Staggered RotaTeq and IPV |
|---|---|---|
| Started | 200 | 200 |
| ≥1 v260 vaccination | 189 | 200 |
| Completed | 185 | 190 |
| Not completed | 15 | 10 |
| Withdrew: Withdrawn by parent/guardian | 15 | 10 |
The immunogenicity of IPV was measured using poliovirus serum neutralizing antibody assay of the National Institutes for Food and Drug Control (NIFDC), Beijing, China. Serum conversion was defined as antibody titer ≥1:8 post-vaccination in baseline seronegative participants or ≥4-fold increase in titer post-vaccination in baseline seropositive participants.
| Percentage of Participants | Concomitant RotaTeq and IPV | Staggered RotaTeq and IPV |
|---|---|---|
| Poliovirus Type 1 | 98.9 | 100.0 |
| Poliovirus Type 2 | 98.3 | 99.5 |
| Poliovirus Type 3 | 100.0 | 99.5 |
The immune response to IPV was measured using poliovirus serum neutralizing antibody assay of the NIFDC, Beijing, China.
| Titers | Concomitant RotaTeq and IPV | Staggered RotaTeq and IPV |
|---|---|---|
| Poliovirus Type 1 | 5600.80 ± 4898.46 | 5344.24 ± 4657.51 |
| Poliovirus Type 2 | 1059.83 ± 951.13 | 1122.43 ± 1002.74 |
| Poliovirus Type 3 | 3405.56 ± 3033.93 | 3261.69 ± 2913.70 |
The immune response to IPV was measured using poliovirus serum neutralizing antibody assay of the NIFDC, Beijing, China.
| Percentage of Participants | Concomitant RotaTeq and IPV | Staggered RotaTeq and IPV |
|---|---|---|
| Poliovirus Type 1 | 100.0 ± 98.0 | 100.0 ± 98.0 |
| Poliovirus Type 2 | 100.0 ± 98.0 | 100.0 ± 98.0 |
| Poliovirus Type 3 | 100.0 ± 98.0 | 100.0 ± 98.0 |
The immune response to IPV was measured using poliovirus serum neutralizing antibody assay of the NIFDC, Beijing, China.
| Percentage of Participants | Concomitant RotaTeq and IPV | Staggered RotaTeq and IPV |
|---|---|---|
| Poliovirus Type 1 | 100.00 ± 98.0 | 100.0 ± 98.0 |
| Poliovirus Type 2 | 100.0 ± 98.0 | 100.0 ± 98.0 |
| Poliovirus Type 3 | 100.0 ± 98.0 | 100.0 ± 98.0 |
Solicited injection-site adverse events (AEs) included erythema, swelling, induration, and pain at the IPV injection-site.
| Percentage of Participants | Concomitant RotaTeq and IPV | Staggered RotaTeq and IPV |
|---|---|---|
| Percentage of Participants With Solicited Injection-Site Adverse Events | 25.4 | 23.0 |
Solicited systemic AEs included diarrhea, vomiting, and elevated temperature (axillary temperature ≥37.5º C).
| Percentage of Participants | Concomitant RotaTeq and IPV | Staggered RotaTeq and IPV |
|---|---|---|
| Elevated temperature | 12.3 | 16.3 |
| Diarrhoea | 13.2 | 21.5 |
| Vomiting | 10.6 | 19.5 |
The percentage of participants with SAEs is presented. An SAE is an AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or another important medical event.
| Percentage of Participants | Concomitant RotaTeq and IPV | Staggered RotaTeq and IPV |
|---|---|---|
| Percentage of Participants With Serious Adverse Events (SAEs) | 3.7 | 5.5 |
Collected over Up to approximately 3.5 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Concomitant RotaTeq and IPV | 0/189 (0%) | 7/189 (3.7%) | 123/189 (65.1%) |
| Staggered RotaTeq and IPV | 0/200 (0%) | 11/200 (5.5%) | 143/200 (71.5%) |
| Event | Concomitant RotaTeq and IPV | Staggered RotaTeq and IPV |
|---|---|---|
| PneumoniaInfections and infestations | 3/189 | 6/200 |
| BronchitisInfections and infestations | 3/189 | 0/200 |
| Motor developmental delayNervous system disorders | 1/189 | 0/200 |
| EnteritisGastrointestinal disorders | 0/189 | 1/200 |
| EpididymitisInfections and infestations | 0/189 | 1/200 |
| Gastrointestinal viral infectionInfections and infestations | 0/189 | 1/200 |
| InfluenzaInfections and infestations | 0/189 | 1/200 |
| Septic shockInfections and infestations | 0/189 | 1/200 |
| Upper respiratory tract infectionInfections and infestations | 0/189 | 1/200 |
| Pneumonia aspirationInfections and infestations | 0/189 | 1/200 |
| Event | Concomitant RotaTeq and IPV | Staggered RotaTeq and IPV |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 33/189 | 50/200 |
| Injection site erythemaGeneral disorders | 45/189 | 41/200 |
| VomitingGastrointestinal disorders | 20/189 | 39/200 |
| PyrexiaGeneral disorders | 30/189 | 37/200 |
| Upper respiratory tract infectionInfections and infestations | 31/189 | 36/200 |
| CoughRespiratory, thoracic and mediastinal disorders | 19/189 | 14/200 |
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 17/189 | 18/200 |
| EczemaSkin and subcutaneous tissue disorders | 14/189 | 12/200 |
| NasopharyngitisInfections and infestations | 14/189 | 14/200 |
| DyspepsiaGastrointestinal disorders | 10/189 | 13/200 |
| Age, Continuous(days) | Concomitant RotaTeq and IPV | Staggered RotaTeq and IPV | Total |
|---|---|---|---|
| Mean | 53.3 ± 4.8 | 53.3 ± 4.6 | 53.3 ± 4.7 |
| Age, Customized(Participants) | Concomitant RotaTeq and IPV | Staggered RotaTeq and IPV | Total |
|---|---|---|---|
| Infants and toddlers (48 to 63 days) | 200 | 200 | 400 |
| Sex: Female, Male(Participants) | Concomitant RotaTeq and IPV | Staggered RotaTeq and IPV | Total |
|---|---|---|---|
| Female | 86 | 93 | 179 |
| Male | 114 | 107 | 221 |
| Ethnicity (NIH/OMB)(Participants) | Concomitant RotaTeq and IPV | Staggered RotaTeq and IPV | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 200 | 200 | 400 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Concomitant RotaTeq and IPV | Staggered RotaTeq and IPV | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 200 | 200 | 400 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Data sharing details ↗ · engagezone.msd.com
Ran from Aug 2020 to primary completion in May 2021, 8 months.
Results were first posted in Feb 2023, 1 year 9 months after primary completion. A results delay was requested in Mar 2022.
Of 21 industry-sponsored phase 3 interventional studies under Gastroenteritis, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 34. This study's 8 months is below that.
Counting every sponsor, half of 25 studies reached it within 19 months; a quarter within 11 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: RotaTeq · Poliovirus Vaccine, Inactivated