A Phase 3 interventional study of Havrix® and M-M-R®II in Hepatitis A, sponsored by GlaxoSmithKline. Completed at 42 sites in United States. Open to participants aged 12 Months to 13 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-31.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention
This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a measles/mumps/rubella vaccine and a varicella (chickenpox) vaccine in children as young as 15 months of age.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
An open, controlled comparison of Havrix™ administered alone or with MMR II and Varivax™. The three groups evaluated are: 1) Havrix™ alone, 2) Havrix™ + MMR II and Varivax™ and 3) MMR II and Varivax™ followed by Havrix™ one month later.
82 studies on the registry are indexed under Hepatitis A; 9 are open to participants now.
This study's enrollment of 1,474 is above the median of 278 across 59 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
Biological: Havrix®
Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
Biological: Havrix® · Biological: M-M-R®II · Biological: VARIVAX®
Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
Biological: Havrix® · Biological: M-M-R®II · Biological: VARIVAX®
2 doses administered intramuscularly
1 dose administered subcutaneously
1 dose administered subcutaneously
Anti-hepatitis A Virus (HAV) Antibody Concentrations in HAV and HAV+MMR+V Groups.
Concentrations are given as geometric mean concentrations (GMCs) expressed as milli-international units per milliliter (mIU/mL).
Time frame: 31 days following the second dose of Havrix®
Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentration Equal or Above the Cut-off Value in HAV and HAV+MMR+V Groups
Anti-HAV antibody cut-off value assessed include 15 milli-international units per milliliter (mIU/mL).
Time frame: 31 days following the second dose of Havrix®
Number of Subjects Seroconverted for Anti-measle, Anti-mumps and Anti-varicella Antibodies in HAV+MMR+V and MMR+V→HAV Groups
Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values assessed include 150 milli-international units per milliliter (mIU/mL) for anti-measles antibodies, 28 Effective Dose 50 (ED50) for anti-mumps antibodies and 1:5 for anti-varicella antibodies.
Time frame: 42 days following the administration of M-M-R®II and VARIVAX®
Number of Subjects With Vaccine Response for Anti-rubella Antibodies in HAV+MMR+V and MMR+V→HAV Groups
Vaccine response is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off value assessed include 10 milli-international units per milliliter (mIU/mL).
Time frame: 42 days following administration of M-M-R®II and VARIVAX®
Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella Antibody Titers in HAV+MMR+V and MMR+V→HAV Groups
Titers are given as geometric mean titers (GMTs).
Time frame: 42 days following the administration of M-M-R®II and VARIVAX®
Anti-hepatitis A Virus (HAV) Antibody Concentrations in HAV and HAV+MMR+V Groups
Concentrations are given as geometric mean concentrations (GMCs).
Time frame: 42 days following the first dose of Havrix®
Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentration Equal or Above the Cut-off Value in HAV and HAV+MMR+V Groups
Anti-HAV antibody cut-off value assessed include 15 milli-international units per millilitre (mIU/mL).
Time frame: 42 days following the first dose of Havrix®
Anti-hepatitis A Virus (HAV) Antibody Concentrations in MMR+V→HAV Group
Concentrations are given as geometric mean concentrations (GMCs).
Time frame: 31 days following the second dose of Havrix®
Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value in MMR+V→HAV Group
Anti-HAV antibody cut-off value assessed include 15 milli-international units per millilitre (mIU/mL).
Time frame: 31 days following the second dose of Havrix®
Number of Subjects With Vaccine Response to Havrix®
Vaccine response was defined as: 1) a detectable anti-hepatitis A virus (HAV) antibody concentration 31 days following the second dose in subjects who were initially seronegative; and 2) a 2-fold increase in anti-HAV antibody concentrations above the pre-study concentration 31 days following the second dose in subjects who were initially seropositive.
Time frame: 31 days following the second dose of Havrix®
Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed include pain, rash (local), redness and swelling.
Time frame: During the 4-day period following each dose of vaccine
Number of Subjects Reporting Solicited General Symptoms
Solicited general symptoms assessed include drowsiness, fever, irritability, loss of appetite and rash (general).
Time frame: During the 4-day period following each dose of vaccine
Number of Subjects Reporting Measles, Mumps, Rubella and Varicella Specific Solicited General Adverse Events
Specific adverse events assessed include papules, vesicles, crusts, parotid/salivary gland swelling and suspected signs of meningitis/febrile seizures.
Time frame: During the 43-day period following each dose of vaccine
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms
Time frame: During the 31-day period following each dose of vaccine
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: During the Active Phase (from Day 0 up to Day 31 after the second dose) and the Extended Safety Follow-up Phase of the study (from Day 31 after the second dose up to study end)
Number of Subjects Reporting New Chronic Illnesses
New Chronic illnesses include autoimmune disorders, asthma, type I diabetes, allergies.
Time frame: During the Active Phase (from Day 0 up to Day 31 after the second dose) and the Extended Safety Follow-up Phase of the study (from Day 31 after the second dose up to study end)
Number of Subjects Reporting Medically Significant Events
Medically significant events include, but are not limited to, diabetes, autoimmune disease, asthma, allergies and/or conditions prompting emergency room or physician office visits that are not related to well-child care, vaccination or common acute illnesses (e.g., upper respiratory infection, otitis media, pharyngitis, gastroenteritis, injury and visits for routine physical examination).
Time frame: During the Active Phase (from Day 0 up to Day 31 after the second dose) and the Extended Safety Follow-up Phase of the study (from Day 31 after the second dose up to study end)
| Milestone | HAV Group | MMR+V→HAV Group | HAV+MMR+V Group |
|---|---|---|---|
| Started | 324 | 455 | 462 |
| Completed | 274 | 366 | 385 |
| Not completed | 50 | 89 | 77 |
| Withdrew: Adverse event | 3 | 0 | 1 |
| Withdrew: Protocol violation | 0 | 3 | 3 |
| Withdrew: Withdrawal by subject | 17 | 37 | 34 |
| Withdrew: Lost to follow-up | 28 | 46 | 37 |
| Withdrew: Other | 2 | 3 | 2 |
Concentrations are given as geometric mean concentrations (GMCs) expressed as milli-international units per milliliter (mIU/mL).
| mIU/mL | HAV Group | MMR+V→HAV Group | HAV+MMR+V Group |
|---|---|---|---|
| Anti-hepatitis A Virus (HAV) Antibody Concentrations in HAV and HAV+MMR+V Groups. | 1390.4 (1186.3 to 1629.6) | — | 1895.2 (1682.7 to 2134.5) |
Anti-HAV antibody cut-off value assessed include 15 milli-international units per milliliter (mIU/mL).
| Participants | HAV Group | MMR+V→HAV Group | HAV+MMR+V Group |
|---|---|---|---|
| Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentration Equal or Above the Cut-off Value in HAV and HAV+MMR+V Groups | 204 | — | 285 |
Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values assessed include 150 milli-international units per milliliter (mIU/mL) for anti-measles antibodies, 28 Effective Dose 50 (ED50) for anti-mumps antibodies and 1:5 for anti-varicella antibodies.
| Participants | HAV Group | MMR+V→HAV Group | HAV+MMR+V Group |
|---|---|---|---|
| Anti-measles | — | 247 | 267 |
| Anti-mumps | — | 193 | 207 |
| Anti-varicella | — | 168 | 187 |
Vaccine response is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off value assessed include 10 milli-international units per milliliter (mIU/mL).
| Participants | HAV Group | MMR+V→HAV Group | HAV+MMR+V Group |
|---|---|---|---|
| Number of Subjects With Vaccine Response for Anti-rubella Antibodies in HAV+MMR+V and MMR+V→HAV Groups | — | 246 | 270 |
Titers are given as geometric mean titers (GMTs).
| titers | HAV Group | MMR+V→HAV Group | HAV+MMR+V Group |
|---|---|---|---|
| Anti-measles | — | 3218.3 (2940.9 to 3521.8) | 3136.3 (2922.0 to 3366.3) |
| Anti-rubella | — | 88.3 (81.9 to 95.3) | 76.0 (70.7 to 81.7) |
| Anti-varicella | — | 281.7 (246.7 to 321.8) | 286.9 (252.1 to 326.5) |
| Anti-mumps | — | 215.7 (190.9 to 243.7) | 170.3 (152.2 to 190.5) |
Concentrations are given as geometric mean concentrations (GMCs).
| milli-international units per milliliter | HAV Group | MMR+V→HAV Group | HAV+MMR+V Group |
|---|---|---|---|
| Anti-hepatitis A Virus (HAV) Antibody Concentrations in HAV and HAV+MMR+V Groups | 43.1 (37.9 to 49.1) | — | 43.5 (39.3 to 48.2) |
Anti-HAV antibody cut-off value assessed include 15 milli-international units per millilitre (mIU/mL).
| Participants | HAV Group | MMR+V→HAV Group | HAV+MMR+V Group |
|---|---|---|---|
| Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentration Equal or Above the Cut-off Value in HAV and HAV+MMR+V Groups | 194 | — | 276 |
Concentrations are given as geometric mean concentrations (GMCs).
| milli-international units per milliliter | HAV Group | MMR+V→HAV Group | HAV+MMR+V Group |
|---|---|---|---|
| Anti-hepatitis A Virus (HAV) Antibody Concentrations in MMR+V→HAV Group | — | 1770.3 (1569.9 to 1996.4) | — |
Anti-HAV antibody cut-off value assessed include 15 milli-international units per millilitre (mIU/mL).
| Participants | HAV Group | MMR+V→HAV Group | HAV+MMR+V Group |
|---|---|---|---|
| Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value in MMR+V→HAV Group | — | 237 | — |
Vaccine response was defined as: 1) a detectable anti-hepatitis A virus (HAV) antibody concentration 31 days following the second dose in subjects who were initially seronegative; and 2) a 2-fold increase in anti-HAV antibody concentrations above the pre-study concentration 31 days following the second dose in subjects who were initially seropositive.
| Participants | HAV Group | MMR+V→HAV Group | HAV+MMR+V Group |
|---|---|---|---|
| Number of Subjects With Vaccine Response to Havrix® | 192 | 224 | 257 |
Solicited local symptoms assessed include pain, rash (local), redness and swelling.
| Participants | HAV Group | MMR+V→HAV Group | HAV+MMR+V Group |
|---|---|---|---|
| Pain | 103 | 162 | 187 |
| Rash (local) | 0 | 3 | 4 |
| Redness | 97 | 149 | 151 |
| Swelling | 45 | 70 | 82 |
Solicited general symptoms assessed include drowsiness, fever, irritability, loss of appetite and rash (general).
| Participants | HAV Group | MMR+V→HAV Group | HAV+MMR+V Group |
|---|---|---|---|
| Drowsiness | 95 | 179 | 178 |
| Fever | 54 | 110 | 80 |
| Irritability | 144 | 238 | 216 |
| Loss of appetite | 94 | 170 | 154 |
| Rash (general) | 5 | 7 | 10 |
Specific adverse events assessed include papules, vesicles, crusts, parotid/salivary gland swelling and suspected signs of meningitis/febrile seizures.
| Participants | HAV Group | MMR+V→HAV Group | HAV+MMR+V Group |
|---|---|---|---|
| Papules | — | 23 | 23 |
| Vesicles | — | 17 | 17 |
| Crusts | — | 12 | 12 |
| Parotid/salivary gland swelling | — | 0 | 1 |
| Suspected signs of meningitidis/febrile seizures | — | 1 | 2 |
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms
| Participants | HAV Group | MMR+V→HAV Group | HAV+MMR+V Group |
|---|---|---|---|
| Number of Subjects Reporting Unsolicited Adverse Events (AEs) | 186 | 286 | 249 |
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
| Participants | HAV Group | MMR+V→HAV Group | HAV+MMR+V Group |
|---|---|---|---|
| Active Phase | 1 | 6 | 5 |
| Extended Safety Follow-up Phase | 6 | 6 | 11 |
New Chronic illnesses include autoimmune disorders, asthma, type I diabetes, allergies.
| Participants | HAV Group | MMR+V→HAV Group | HAV+MMR+V Group |
|---|---|---|---|
| Active Phase | 0 | 0 | 0 |
| Extended Safety Follow-Up Phase | 0 | 0 | 0 |
Medically significant events include, but are not limited to, diabetes, autoimmune disease, asthma, allergies and/or conditions prompting emergency room or physician office visits that are not related to well-child care, vaccination or common acute illnesses (e.g., upper respiratory infection, otitis media, pharyngitis, gastroenteritis, injury and visits for routine physical examination).
| Participants | HAV Group | MMR+V→HAV Group | HAV+MMR+V Group |
|---|---|---|---|
| Active Phase | 0 | 0 | 0 |
| Extended Safety Follow-Up Phase | 0 | 0 | 0 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HAV Group | — | 7/324 (2.2%) | 251/324 (77.5%) |
| MMR+V→HAV Group | — | 12/455 (2.6%) | 366/455 (80.4%) |
| HAV+MMR+V Group | — | 16/462 (3.5%) | 363/462 (78.6%) |
| Event | HAV Group | MMR+V→HAV Group | HAV+MMR+V Group |
|---|---|---|---|
| DehydratationMetabolism and nutrition disorders | 2/324 | 1/455 | 2/462 |
| AutismNervous system disorders | 1/324 | 0/455 | 1/462 |
| GastroenteritisInfections and infestations | 1/324 | 0/455 | 1/462 |
| Respiratory syncytial virus bronchiolitisInfections and infestations | 1/324 | 1/455 | 0/462 |
| ConvulsionNervous system disorders | 1/324 | 0/455 | 0/462 |
| Groin abscessInfections and infestations | 1/324 | 0/455 | 0/462 |
| LeukaemiaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/324 | 0/455 | 0/462 |
| BronchiolitisInfections and infestations | 0/324 | 1/455 | 1/462 |
| BronchitisInfections and infestations | 0/324 | 1/455 | 1/462 |
| Burns second degreeInjury, poisoning and procedural complications | 0/324 | 1/455 | 0/462 |
| Event | HAV Group | MMR+V→HAV Group | HAV+MMR+V Group |
|---|---|---|---|
| IrritabilityGeneral disorders | 144/304 | 238/411 | 216/424 |
| PainGeneral disorders | 103/304 | 162/411 | 187/419 |
| DrowsinessGeneral disorders | 95/304 | 179/411 | 178/424 |
| Loss of appetiteGeneral disorders | 94/304 | 170/411 | 154/424 |
| RednessGeneral disorders | 97/304 | 149/411 | 151/419 |
| FeverGeneral disorders | 54/304 | 110/411 | 80/424 |
| SwellingGeneral disorders | 45/304 | 70/411 | 82/419 |
| Otitis mediaInfections and infestations | 35/324 | 79/455 | 65/462 |
| PyrexiaGeneral disorders | 34/324 | 68/455 | 56/462 |
| Upper respiratory tract infectionInfections and infestations | 31/324 | 64/455 | 58/462 |
| Age, Continuous(months) | HAV Group | MMR+V→HAV Group | HAV+MMR+V Group | Total |
|---|---|---|---|---|
| Mean | 15.0 ± 0.27 | 15.0 ± 0.22 | 15.0 ± 0.25 | 15.0 ± 0.25 |
| Sex: Female, Male(Participants) | HAV Group | MMR+V→HAV Group | HAV+MMR+V Group | Total |
|---|---|---|---|---|
| Female | 154 | 208 | 232 | 594 |
| Male | 170 | 247 | 230 | 647 |
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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