A Post-Marketing Study of the Immunogenicity of Somatropin (Ribosomal Deoxyribo Nucleic Acid [rDNA] Origin) Injection (Nutropin AQ®) in Children With Growth Hormone Deficiency

Inclusion Criteria:

- Bone age less than equal to ( determined by X-ray of the left hand and wrist using Greulich and Pyle method and
obtained within the 12 months prior to enrollment

- Prepubertal (Tanner I) males and females by physical examination

- Diagnosis of GHD (stimulated GH less than [<] 10 nanograms per milliliter [ng/mL]) by
two standard pharmacologic tests obtained up to 12 months prior to informed
consent/assent

- Normal thyroid function test within the 12 months prior to informed consent/assent

- Normal complete blood counts within 12 months prior to informed consent/assent

- Documentation of prior height and weight measurements, with height standard deviation
score (SDS)
Exclusion Criteria:

- Any previous rhGH treatment

- Short stature etiologies other than GHD

- Acute critical illness or uncontrolled chronic illness, which in the opinion of the
investigator and medical monitor, would interfere with participation in this study,
interpretation of the data, or pose a risk to participant safety

- Chronic illnesses such as inflammatory bowel disease, celiac disease, heart disease,
and diabetes

- Bone diseases such as achondroplasia or hypochondroplasia, intracranial tumor,
irradiation, and traumatic brain injury

- Participants receiving oral or inhaled chronic corticosteroid therapy (greater than
[>] 3 months) for other medical conditions other than central adrenal insufficiency

- Participants who require higher (2 times or greater than maintenance) doses of
corticosteroids for more than 5 days in the 6 months prior to enrollment in the study

- Participants with active malignancy or any other condition that the investigator
believes would pose a significant hazard to the participant if rhGH were initiated

- Females with Turner syndrome regardless of their GH status

- Prader-Willi syndrome regardless of GH status

- Born small for gestational age regardless of GH status

- Presence of scoliosis requiring monitoring

- Previous participation in another clinical trial or investigation of GH, treatment for
growth failure, or treatment with a biologic agent

- Participants with closed epiphyses

- Participants with a known hypersensitivity to somatropin, excipients, or diluent