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DiphtheriaPhase 2NCT00133445

Pentavalent DTaP-Hep B-IPV

A Phase 2 study testing DTaP-Hep B-IPV Vaccine and Monovalent Hep B Vaccine in people with Diphtheria and Hepatitis B, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

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

The purpose of this study is to evaluate the safety of administering a combination vaccine (DTaP-HepB-IPV; Pediarix™) to infants at birth, 2 and 6 months compared to the administration of a HepB vaccine at birth and the same combination vaccine at 2, 4, and 6 months of age. Read more about this study

Who is it for?
Ages Up to 5 daysHealthy volunteers can take part
Conditions the study is for
Diphtheria, Hepatitis B, Poliomyelitis
What is being tested?
DTaP-Hep B-IPV Vaccine and Monovalent Hep B Vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
5 participants
Where
1 siteUnited States
Study dates
Dec 2005to Aug 2006
Phase
Phase 2
Are there results?
None posted in the registry

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 Up to 5 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Prenatal Inclusion Criteria
  • Generally healthy, pregnant mother
  • Mother will deliver at a Kaiser Permanente Medical Center participating in the study
  • Ability of the parent(s) to understand and comply with the requirements of the protocol
  • Signed informed consent by parent(s)
  • Birth Inclusion Criteria
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  • Healthy newborn 0 to 5 days of age
  • Gestational age greater than or equal to 37 weeks to less than or equal to 42 weeks and birth weight greater than 2500 grams
  • Signed informed consent obtained
  • Mother continues to be eligible by prenatal screening criteria
  • Newborn will receive future well child care at a Kaiser Permanente study clinic
  • After reviewing with parent(s) the study procedures and informed consent, parent wishes to continue in the study

Who cannot join

  • Prenatal Exclusion Criteria
  • Mother positive for hepatitis B surface antigen (HBsAg) or whose antigen status is unknown
  • Mother positive for human immunodeficiency virus (HIV) or whose antigen status is unknown
  • Mother positive for rapid plasma reagin (RPR) (syphilis) or whose antigen status is unknown
  • Mother or immediate family member has impaired immunologic function
  • Mother is expected to take immune suppressant medications during the last trimester of pregnancy
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  • Mother is expected to receive blood, blood products or immunoglobulin preparation (including hepatitis B immune globulin [HBIG]) during the last trimester of the pregnancy
  • Mother with insulin dependent diabetes
  • Mother with pre-eclampsia, eclampsia or abruptio placentae
  • Pregnancy associated with known congenital defects
  • Mother participating in another study with a non-Food and Drug Administration (FDA) approved drug, vaccine or device
  • Parent(s)/guardian cannot be contacted by telephone
  • Parent(s)/guardian will not continue well child care at a Kaiser Permanente study clinic
  • Mother who is requesting that cord blood be retained for stem cell preservation
  • Other maternal conditions that, in the opinion of the investigator, would interfere with the study
  • Birth Exclusion Criteria
  • Current receipt of antibiotics for suspected infection in mother or newborn (based on presence of maternal fever greater than or equal to 38.0 degrees Celsius or prolonged rupture of membranes greater than or equal to 18 hours)
  • Rectal temperature greater than or equal to 38.0 degrees Celsius
  • Newborn receiving resuscitation [including intubation, mechanical ventilation or intravenous (IV) medication] at birth
  • Suspected medical, congenital, developmental or surgical disease, including immunodeficiency, neurology disorder or seizure disorder, severe congenital anomalies or multi-organ dysfunction
  • Prior receipt of hepatitis B vaccine or any other vaccine
  • Received or plans to receive any immunosuppressant medication
  • Receipt of blood products or immunoglobulin [including Hepatitis B Immune Globulin (HBIG)]
  • Clinically significant findings on review of medical history and physical exam determined by the investigator or sub-investigator to be sufficient for exclusion
  • Mother of newborn with insulin dependent diabetes
  • Mother of newborn with pre-eclampsia, eclampsia or abruptio placentae
  • Mother of newborn positive for HBsAG, HIV or RPR (syphilis) or whose antigen status is unknown
  • Impaired immunologic function in newborn or family member
  • Any condition determined by the investigator that would interfere with the evaluation of the vaccine or be a potential health risk to the subject
  • Newborn is participating in another research study or has received a non-FDA approved drug or vaccine (excluding formula preparations) prior to study entry
  • Parent(s)/guardian who are unable to be contacted by telephone

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCLA Center For Vaccine Research

    Torrance, California, 90502

Other trials in United States

About this study

Official title: Randomized, Single Blinded Study of the Safety and Immunogenicity of Pentavalent DTaP-Hep B-IPV Combination Vaccine (Pediarix™; GlaxoSmithKline (GSK) Biologicals) Administered to Healthy Neonates and Infants at Birth, 2, and 6 Months of Age Compared to a Routine Infant Schedule at 2, 4, and 6 Months of Age

The purpose of this study is to evaluate the safety of administering a combination vaccine (DTaP-HepB-IPV; Pediarix™) to infants at birth, 2 and 6 months compared to the administration of a HepB vaccine at birth and the same combination vaccine at 2, 4, and 6 months of age. Additionally, researchers will assess the body's antibody response (proteins produced by the body's immune system that help fight infections) following each vaccine dose. The study will enroll 5 healthy newborns, ages 0-5 days. Participants will be involved in study related procedures for up to 288 days, including blood sample collection and 5 study visits.

Read the detailed description

Routine immunization at birth is standard for hepatitis B in the United States (US) and for hepatitis B, polio and tuberculosis (BCG) in many countries. Other vaccines have not been routinely administered at birth largely due to concerns relating to immaturity of the neonatal immune system and the possibility of reduced immune response to vaccine antigens. With the recent licensure in the US of a pentavalent combination vaccine (DTaP-Hep B-IPV; Pediarix™) researchers propose to evaluate a new immunization schedule that includes a birth dose of this vaccine, in an effort to determine adequacy of neonatal immune response to the study vaccine antigens. The primary objectives of this study are: to evaluate the safety of administering the pentavalent combination vaccine (DTaP-HepB-IPV; Pediarix™) to infants at birth, two and six months of age compared to the administration of a hepatitis B vaccine (Engerix-B) at birth and the same pentavalent combination vaccine at two, four and six months of age; and to assess age specific antibody response following each vaccine dose. Five healthy newborns; 0 to 5 days of age, greater than or equal to 37 weeks gestation, and greater than 2500 gm birth weight were recruited from two Southern California Kaiser Permanente medical centers. Infants were randomized to one of 2 study groups: Group A received DTaP-HepB-IPV (Pediarix™) vaccine along with other required vaccines at birth, two, six months of age; Group B received the monovalent hepatitis B vaccine (Engerix-B) at birth, the DTaP-HepB-IPV (Pediarix™) vaccine with other vaccines at two, four and six months. Children will be evaluated for post-vaccination adverse events. Blood will be collected and immunogenicity evaluated by standardized humoral immunologic assays. The main outcome measures are to assess immune responses to each vaccine antigen over time, antibodies to pertussis (PT, FHA, PRN), diphtheria, tetanus, haemophilus influenzae type b (Hib), polio (Types 1, 2, 3) and hepatitis B (HbsAg). The secondary outcome measures are to assess vaccine safety, systemic and local immediate reactions.

Being tested
DTaP-Hep B-IPV Vaccine, Monovalent Hep B Vaccine, Placebo
Keywords
Pentavalent vaccine, Pediarix, DTaP-Hep B-IPV vaccine
Medical subject headings
Diphtheria, Hepatitis B, Poliomyelitis, Whooping Cough, Tetanus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DTaP-Hep B-IPV VaccineBiological

    U.S. licensed 13-Dec-2002. Dosage equal to 0.5 mL administered intramuscularly. Combination vaccine.

  • Monovalent Hep B VaccineBiological

    U.S. licensed monovalent hepatitis B vaccine; each 0.5 mL dose contains 10 mcg of hepatitis B surface antigen absorbed on 0.25 mg aluminum hydroxide. The vaccine is given to infants as a 0.5 mL dose intramuscularly.

  • PlaceboDrug

    Commercially prepared normal saline. The dose will be 0.5 mL administered intramuscularly.

Study groups in NCT00133445
Study groupRoleWhat they receive
Group AExperimentalGroup A will receive DTaP-HepB-IPV (Pediarix™) vaccine along with other required vaccines at birth, 2 and 6 months of age.
Receives: Biological: DTaP-Hep B-IPV Vaccine; Drug: Placebo
Group BActive comparatorGroup B will receive the monovalent HepB vaccine (Engerix-B) at birth, the DTaP-HepB-IPV (Pediarix™) vaccine with other vaccines at 2, 4 and 6 months of age.
Receives: Biological: DTaP-Hep B-IPV Vaccine; Biological: Monovalent Hep B Vaccine

What is being measured

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

  1. To assess the immune responses to each vaccine antigen over time, antibodies to pertussis (PT, FHA, PRN), diphtheria, tetanus, Hib, polio (Types 1, 2, 3) and hepatitis B (HbsAg) will be evaluated.

    Measured: Day 0-5, Day 53-70, Day 113-130, Day 173-190, and Visit 4 + (28-42 days).

Secondary outcomes (1)

  1. To assess vaccine safety, systemic and local immediate reactions.

    Measured: 30 mins after each immunization; 7 days following each vaccination; contacted 2-3 and 8 days following each vaccination to collect AE information; SAEs will be collected throughout study participation.

Timeline

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

  1. First posted23 Aug 2005 (estimated)
  2. Study startDec 2005
  3. Primary completionAug 2006
  4. Study completionAug 2006

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00133445
Sponsor's protocol ID
03-062
Status last verified
Oct 2009
First submitted
19 Aug 2005
Last updated
7 Nov 2011
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DTaP-Hep B-IPV Vaccine and Monovalent Hep B Vaccine in people with Diphtheria and Hepatitis B, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

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 12 inclusion and 31 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 7 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To assess the immune responses to each vaccine antigen over time, antibodies to pertussis (PT, FHA, PRN), diphtheria, tetanus, Hib, polio (Types 1, 2, 3) and hepatitis B (HbsAg) will be evaluated. (time frame: Day 0-5, Day 53-70, Day 113-130, Day 173-190, and Visit 4 + (28-42 days).). 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 NCT00133445.

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 7 Nov 2011.

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